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Clinical Trial Results:
A phase III, double blind (observer-blind), randomized, controlled multi-center study to evaluate, in infants and children, the efficacy of the RTS,S/AS01E candidate vaccine against malaria disease caused by P. falciparum infection, across diverse malaria transmission settings in Africa.

Summary
EudraCT number	2012-005716-26
Trial protocol	Outside EU/EEA
Global end of trial date	31 Jan 2014
Results information
Results version number	v3(current)
This version publication date	15 Feb 2023
First version publication date	01 Aug 2015
Other versions	v1 , v2
Version creation reason

Trial information Top of page
Trial identification
Sponsor protocol code	110021
Additional study identifiers
ISRCTN number	-
US NCT number	NCT00866619
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	GlaxoSmithKline
Sponsor organisation address	Rue de l’Institut 89, Rixensart, Belgium, B-1330
Public contact	Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 8664357343, GSKClinicalSupportHD@gsk.com
Scientific contact	Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 8664357343, GSKClinicalSupportHD@gsk.com
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	Yes
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	15 Jul 2014
Is this the analysis of the primary completion data?	No
Global end of trial reached?	Yes
Global end of trial date	31 Jan 2014
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	-To evaluate the protective efficacy of RTS,S/AS01E against clinical malaria disease caused by Plasmodium falciparum in African children aged at first dose between 6-12 weeks and received the vaccine in co-administration with DTPwHepB/Hib antigens (Tritanrix HepB/Hib) and OPV. Duration of follow-up was for a minimum of 12 months and a maximum of 18 months after completion of the primary course (Primary Analysis). -To evaluate the protective efficacy of RTS,S/AS01E against clinical malaria disease caused by Plasmodium falciparum in African children aged at first dose between 5-17 months. Duration of follow-up was for a minimum of 12 months and a maximum of 18 months after completion of the primary course (Primary Analysis).
Protection of trial subjects	The vaccinees were observed closely for at least 30 minutes following the administration of all vaccines used in the study, with appropriate medical treatment readily available in case of an anaphylactic reaction. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Children and infants who received an incomplete primary vaccination schedule (not the 3 doses within the expected timings) did not receive the booster dose of RTS,S/AS01E or control vaccine.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	27 Mar 2009
Long term follow-up planned	Yes
Long term follow-up rationale	Safety, Efficacy
Long term follow-up duration	12 Months
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Tanzania, United Republic of: 3210
Country: Number of subjects enrolled	Ghana: 2621
Country: Number of subjects enrolled	Mozambique: 1637
Country: Number of subjects enrolled	Malawi: 1626
Country: Number of subjects enrolled	Gabon: 930
Country: Number of subjects enrolled	Kenya: 4154
Country: Number of subjects enrolled	Burkina Faso: 1281
Worldwide total number of subjects	15459
EEA total number of subjects	0
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	15459
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	0
From 65 to 84 years	0
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	The study included 3 phases, a primary (PRI) phase (Months 0-3) and a booster (BST) phase at Month 20, each followed by a related PRI/BST efficacy, immunogenicity and safety (EIS) follow-up (FU) phase, and an EIS extension, from Month 32 to the median of Month 48 or Month 38 time point.
Pre-assignment
Screening details	Screening included the following: check for inclusion/exclusion criteria, vaccination contraindications/precautions, subjects’ medical history and signing informed consent forms.
Period 1
Period 1 title	Overall Study (overall period)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator, Monitor, Data analyst
Arms
Are arms mutually exclusive	Yes
Arm title	GSK257049 [5-17M] Group
Arm description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Arm type	Experimental
Investigational medicinal product name	Malaria Vaccine 257049
Investigational medicinal product code	GSK257049
Other name
Pharmaceutical forms	Powder and suspension for suspension for injection
Routes of administration	Intramuscular use
Dosage and administration details	3 doses administered intramuscularly into the left deltoid
Investigational medicinal product name	Meningococcal C Conjugate Vaccine
Investigational medicinal product code
Other name	Menjugate
Pharmaceutical forms	Powder and suspension for suspension for injection, Powder and solvent for suspension for injection
Routes of administration	Intramuscular use
Dosage and administration details	3 doses administered intramuscularly into the left deltoid.
Arm title	GSK257049 [6-12W] Group
Arm description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Arm type	Experimental
Investigational medicinal product name	257049
Investigational medicinal product code	GSK257049
Other name
Pharmaceutical forms	Powder and suspension for suspension for injection
Routes of administration	Intramuscular use
Dosage and administration details	3 doses administered intramuscularly into the left deltoid
Investigational medicinal product name	Polio Sabin Oral Polio Vaccine (GSK)
Investigational medicinal product code
Other name
Pharmaceutical forms	Oral suspension
Routes of administration	Oral use
Dosage and administration details	3 doses administered orally
Investigational medicinal product name	TritanrixHepB/Hib
Investigational medicinal product code
Other name
Pharmaceutical forms	Powder and suspension for suspension for injection, Powder and solvent for suspension for injection, Suspension for injection, Powder and solution for solution for injection, Oral suspension
Routes of administration	Intramuscular use, Oral use
Dosage and administration details	3 doses administered intramuscularly into the left deltoid
Investigational medicinal product name	Meningococcal C Conjugate Vaccine
Investigational medicinal product code
Other name	Menjugate
Pharmaceutical forms	Powder and suspension for suspension for injection, Powder and solvent for suspension for injection
Routes of administration	Intramuscular use
Dosage and administration details	3 doses administered intramuscularly into the left deltoid.
Arm title	VeroRab Comparator [5-17M] Group
Arm description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Arm type	Active comparator
Investigational medicinal product name	Meningococcal C Conjugate Vaccine
Investigational medicinal product code
Other name	Menjugate
Pharmaceutical forms	Powder and suspension for suspension for injection, Powder and solvent for suspension for injection
Routes of administration	Intramuscular use
Dosage and administration details	3 doses administered intramuscularly into the left deltoid
Investigational medicinal product name	Cell-culture rabies vaccine
Investigational medicinal product code
Other name	VeroRab
Pharmaceutical forms	Powder and suspension for suspension for injection, Powder and solvent for suspension for injection
Routes of administration	Intramuscular use
Dosage and administration details	3 doses administered intramuscularly into the left deltoid
Arm title	Menjugate Comparator [6-12W] Group
Arm description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Arm type	Experimental
Investigational medicinal product name	Meningococcal C Conjugate Vaccine
Investigational medicinal product code
Other name	Menjugate
Pharmaceutical forms	Powder and suspension for suspension for injection, Powder and solvent for suspension for injection
Routes of administration	Intramuscular use
Dosage and administration details	3 doses administered intramuscularly into the left deltoid
Investigational medicinal product name	TritanrixHepB/Hib
Investigational medicinal product code
Other name
Pharmaceutical forms	Powder and suspension for suspension for injection, Powder and solvent for suspension for injection, Suspension for injection, Powder and solution for solution for injection, Oral suspension
Routes of administration	Intramuscular use, Oral use
Dosage and administration details	3 doses administered intramuscularly into the left deltoid
Investigational medicinal product name	Polio Sabin Oral Polio Vaccine (GSK)
Investigational medicinal product code
Other name
Pharmaceutical forms	Powder and solvent for suspension for injection, Suspension for injection, Oral suspension
Routes of administration	Oral use
Dosage and administration details	3 doses administered orally
Number of subjects in period 1 GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Started 5948 4358 2974 2179 Completed 4102 3088 2085 1549 Not completed 1846 1270 889 630      Consent withdrawn by subject 587 295 272 144      Adverse event, non-fatal 112 106 47 44      Lost to follow-up 1145 830 568 425      Protocol deviation 2 39 2 17

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	GSK257049 [5-17M] Group
Reporting group description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Reporting group title	GSK257049 [6-12W] Group
Reporting group description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Reporting group title	VeroRab Comparator [5-17M] Group
Reporting group description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Reporting group title	Menjugate Comparator [6-12W] Group
Reporting group description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Reporting group values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Total Number of subjects 5948 4358 2974 2179 15459 Age categorical Units: Subjects     In utero 0 0 0 0 0     Preterm newborn infants (gestational age < 37 wks) 0 0 0 0 0     Newborns (0-27 days) 0 0 0 0 0     Infants and toddlers (28 days-23 months) 5948 4358 2974 2179 15459     Children (2-11 years) 0 0 0 0 0     Adolescents (12-17 years) 0 0 0 0 0     Adults (18-64 years) 0 0 0 0 0     From 65-84 years 0 0 0 0 0     85 years and over 0 0 0 0 0 Age Continuous Units: Months     arithmetic mean (standard deviation) 10.6 ± 3.8 1.2 ± 0.4 10.6 ± 3.7 1.2 ± 0.4 - Sex: Female, Male Units: Participants     Female 2967 2124 1503 1100 7694     Male 2981 2234 1471 1079 7765
Subject analysis sets
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 Group
Subject analysis set type	Per protocol
Subject analysis set description	For the purpose of the analysis, GSK257049 [5-17M] and GSK257049 [6-12W] groups have been pooled into a single group.
Subject analysis set title	Comparator Group
Subject analysis set type	Per protocol
Subject analysis set description	For the purpose of the analysis, VeroRab Comparator [5-17M] and Menjugate Comparator [6-12W] groups have been pooled into a single group.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled group between GSK257049 [5-17M] Group and GSK257049 [6-12W] Group.
Subject analysis set title	GSK257049 -GSK257049 Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled group between GSK257049 -GSK257049 [5-17M] Group and GSK257049 -GSK257049 [6-12W] Group.
Subject analysis set title	GSK257049 - Menjugate Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled group between GSK257049 - Menjugate [5-17M] Group and GSK257049 - Menjugate [6-12W] Group.
Subject analysis set title	Comparator Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled Group between VeroRab Comparator [5-17M] Group and Menjugate Comparator [6-12W] Group.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 -GSK257049 Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled group between GSK257049 -GSK257049 [5-17M] Group and GSK257049 -GSK257049 [6-12W] Group.
Subject analysis set title	GSK257049 - Menjugate Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled group between GSK257049 - Menjugate [5-17M] Group and GSK257049 - Menjugate [6-12W] Group.
Subject analysis set title	Comparator Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled Group between VeroRab Comparator [5-17M] Group and Menjugate Comparator [6-12W] Group.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis sets values GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 Group Comparator Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - Menjugate [5-17M] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - Menjugate [5-17M] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 Group GSK257049 -GSK257049 Group GSK257049 - Menjugate Group Comparator Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 -GSK257049 Group GSK257049 - Menjugate Group Comparator Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects 2276 2306 1985 2005 2017 2057 1743 1788 1784 1838 1516 1548 8597 4364 1935 1967 1637 1656 2363 2382 1726 1731 442 438 530 569 104 101 101 103 545 639 182 214 465 546 156 420 95 134 641 639 608 625 2447 2472 1825 1837 605 617 2976 2972 2180 2178 2681 2719 1966 1996 84 33 35 41 273 297 230 208 51 54 48 277 304 232 211 48 50 48 47 1509 1500 1116 1118 Age categorical Units: Subjects     In utero     Preterm newborn infants (gestational age < 37 wks)     Newborns (0-27 days)     Infants and toddlers (28 days-23 months)     Children (2-11 years)     Adolescents (12-17 years)     Adults (18-64 years)     From 65-84 years     85 years and over Age Continuous Units: Months     arithmetic mean (standard deviation) 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 10 ± 3 Sex: Female, Male Units: Participants     Female 1123 1137 967 976 2000 2000 1000 1000 1000 1000 1000 1000 8000 4000 1000 1000 1000 1000 2000 2000 1000 1000 400 400 500 500 100 100 100 100 500 600 100 200 400 500 100 400 90 100 600 600 600 600 2000 2000 1000 1000 600 600 2000 2000 2000 2000 2000 2000 1000 1000 80 30 30 40 200 200 200 200 50 54 48 277 304 232 211 48 50 48 47 1509     Male 1153 1169 1018 1029 17 57 743 788 784 838 516 548 597 364 935 967 637 656 363 382 726 731 42 38 30 69 4 1 1 3 45 39 82 14 65 46 56 20 5 34 41 39 8 25 447 472 825 837 5 17 976 972 180 178 681 719 966 996 4 3 5 1 73 97 30 8 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	GSK257049 [5-17M] Group
Reporting group description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Reporting group title	GSK257049 [6-12W] Group
Reporting group description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Reporting group title	VeroRab Comparator [5-17M] Group
Reporting group description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Reporting group title	Menjugate Comparator [6-12W] Group
Reporting group description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 Group
Subject analysis set type	Per protocol
Subject analysis set description	For the purpose of the analysis, GSK257049 [5-17M] and GSK257049 [6-12W] groups have been pooled into a single group.
Subject analysis set title	Comparator Group
Subject analysis set type	Per protocol
Subject analysis set description	For the purpose of the analysis, VeroRab Comparator [5-17M] and Menjugate Comparator [6-12W] groups have been pooled into a single group.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled group between GSK257049 [5-17M] Group and GSK257049 [6-12W] Group.
Subject analysis set title	GSK257049 -GSK257049 Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled group between GSK257049 -GSK257049 [5-17M] Group and GSK257049 -GSK257049 [6-12W] Group.
Subject analysis set title	GSK257049 - Menjugate Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled group between GSK257049 - Menjugate [5-17M] Group and GSK257049 - Menjugate [6-12W] Group.
Subject analysis set title	Comparator Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled Group between VeroRab Comparator [5-17M] Group and Menjugate Comparator [6-12W] Group.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 -GSK257049 Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled group between GSK257049 -GSK257049 [5-17M] Group and GSK257049 -GSK257049 [6-12W] Group.
Subject analysis set title	GSK257049 - Menjugate Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled group between GSK257049 - Menjugate [5-17M] Group and GSK257049 - Menjugate [6-12W] Group.
Subject analysis set title	Comparator Group
Subject analysis set type	Per protocol
Subject analysis set description	Pooled Group between VeroRab Comparator [5-17M] Group and Menjugate Comparator [6-12W] Group.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - GSK257049 [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 - Menjugate [5-17M] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Subject analysis set title	GSK257049 -GSK257049 [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Subject analysis set title	GSK257049 - Menjugate [6-12W] Group
Subject analysis set type	Per protocol
Subject analysis set description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.

End points Top of page

Primary: Rate of first or only clinical episode of Plasmodium falciparum (P. falciparum) malaria infection (CPFMI), or clinical malaria episode of Primary Case Definition (CPFMI-PCD) Top of page
End point title	Rate of first or only clinical episode of Plasmodium falciparum (P. falciparum) malaria infection (CPFMI), or clinical malaria episode of Primary Case Definition (CPFMI-PCD) [1]
End point description	A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia was greater than (>) 5000 parasites per microliter (µL) accompanied by the presence of fever [axillary temperature greater than or equal to (≥) 37.5°C] at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is person-year rate in each group (n/T). Analysis for this outcome was solely performed on subjects in the 5-17 months age category.
End point type	Primary
End point timeframe	From Month 2.5 to Month 14
Notes [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values GSK257049 [5-17M] Group VeroRab Comparator [5-17M] Group Number of subjects analysed 2830 1466 Units: events per person-year     number (not applicable) 0.435 0.833
Statistical analysis title	RfoCPFMI comparison
Statistical analysis description	The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus [Hazard Ratio (HR) in GSK257049 [5-17M] Group (HR1) divided by HR in control VeroRab Comparator [5-17M] Group (HR2)]; i. e. 1 - (HR1/HR2).
Comparison groups	GSK257049 [5-17M] Group v VeroRab Comparator [5-17M] Group
Number of subjects included in analysis	4296
Analysis specification	Pre-specified
Analysis type	[2]
P-value	< 0.0001
Method	Regression, Cox
Parameter type	Vaccine efficacy
Point estimate	55.8
Confidence interval
level	97.5%
sides	2-sided
lower limit	50.6
upper limit	60.4
Notes [2] - Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE > 0.

Primary: Rate of first or only clinical episode of Plasmodium falciparum (P. falciparum) malaria infection (CPFMI), or clinical malaria episode of Primary Case Definition (CPFMI-PCD) Top of page

Primary: Rate of first or only clinical episode of P. falciparum malaria infection (CPFMI), or clinical malaria episode of Primary Case Definition (CPFMI-PCD) Top of page
End point title	Rate of first or only clinical episode of P. falciparum malaria infection (CPFMI), or clinical malaria episode of Primary Case Definition (CPFMI-PCD) [3]
End point description	A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia > 5000 parasites/µL was accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is, person-year rate in each group (n/T). Analysis for this outcome was solely performed on subjects in the 6-12 weeks (6-12W) age category.
End point type	Primary
End point timeframe	From Month 2.5 to Month 14
Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values GSK257049 [6-12W] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 3995 2008 Units: events per person-year     number (not applicable) 0.367 0.484
Statistical analysis title	RfoCPFMI comparison
Statistical analysis description	The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus [Hazard Ratio (HR) in GSK257049 [6-12W] Group (HR1) divided by HR in control Menjugate Comparator [6-12W] Group (HR2)]; i. e. 1 - (HR1/HR2).
Comparison groups	GSK257049 [6-12W] Group v Menjugate Comparator [6-12W] Group
Number of subjects included in analysis	6003
Analysis specification	Pre-specified
Analysis type	[4]
P-value	< 0.0001
Method	Regression, Cox
Parameter type	Vaccine efficacy
Point estimate	31.315
Confidence interval
level	97.5%
sides	2-sided
lower limit	23.556
upper limit	38.286
Notes [4] - Point estimate of efficacy was adjusted for study site as stratification factor for the analysis. Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE > 0.

Primary: Rate of first or only clinical episode of P. falciparum malaria infection (CPFMI), or clinical malaria episode of Primary Case Definition (CPFMI-PCD) Top of page

Secondary: Rate of all episodes of P. falciparum clinical malaria infection (CPFMI) of PCD and of secondary case definitions (SCD) 1, SCD 2 and SCD 3 Top of page
End point title	Rate of all episodes of P. falciparum clinical malaria infection (CPFMI) of PCD and of secondary case definitions (SCD) 1, SCD 2 and SCD 3
End point description	PCD=malaria episode with P. falciparum asexual parasitemia (PFAP) > 5000 parasites/µL accompanied by fever and occurring in a child unwell brought for treatment to a healthcare facility or a case of malaria meeting the PCD of severe malaria disease. SCD1=malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. SCD2=malaria episode with PFAP > 500 parasites/μL and fever at time of presentation in a subject unwell brought for treatment to a healthcare facility. SCD3=malaria episode with PFAP > 20.000 parasites/μL and fever at time of presentation in a subject unwell and brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.
End point type	Secondary
End point timeframe	From Month 2.5 to Month 14
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 2830 3995 1466 2008 Units: events per person-year number (not applicable)     PCD 0.735 0.639 1.468 0.908     SCD1 1.224 0.989 2.312 1.403     SCD2 0.847 0.736 1.628 1.031     SCD3 0.625 0.515 1.244 0.731
No statistical analyses for this end point

Secondary: Rate of all episodes of P. falciparum clinical malaria infection (CPFMI) of PCD and of secondary case definitions (SCD) 1, SCD 2 and SCD 3 Top of page

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of PCD, overall and by center Top of page
End point title	Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of PCD, overall and by center
End point description	PCD = malaria episode with PFAP > 5000 parasites/µL accompanied by fever and occurring in a child unwell brought for treatment to a healthcare facility or a case of malaria meeting the PCD of severe malaria disease (see below endpoints on severe malaria for details). Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are by center and across centers, and are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.
End point type	Secondary
End point timeframe	From Month 2.5 to Month 20
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 4557 3996 2328 2007 Units: events per person-year number (not applicable)     PCD – Agogo 0.56 0.64 1.16 0.79     PCD – Bagamoyo 0.1 0.08 0.28 0.14     PCD – Kilifi 0.01 0.04 0.04 0.02     PCD – Kintampo 1.01 1.53 1.85 1.49     PCD – Kombewa 1.21 0.94 1.87 1.32     PCD – Korogwe 0.04 0.03 0.11 0.05     PCD – Lambarene 0.11 0.11 0.2 0.12     PCD – Lilongwe 0.2 0.3 0.32 0.5     PCD – Manhica 0 0.1 0 0.12     PCD – Nanoro 1.42 1.93 2.4 2.39     PCD – Siaya 2.01 2.03 3.31 2.75     PCD – Across 0.69 0.71 1.17 0.92
No statistical analyses for this end point

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of PCD, overall and by center Top of page

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of SCD1, SCD2 and SCD3 (overall) Top of page
End point title	Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of SCD1, SCD2 and SCD3 (overall)
End point description	SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. SCD2 = malaria episode with PFAP > 500 parasites/μL and fever at time of presentation in a subject unwell brought for treatment to a healthcare facility. SCD3 = malaria episode with PFAP > 20.000 parasites/μL and fever at time of presentation in a subject unwell and brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are across centers, and are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.
End point type	Secondary
End point timeframe	From Month 2.5 to Month 20
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 4557 3996 2328 2007 Units: events per person-year number (not applicable)     SCD1 1.09 1.09 1.78 1.42     SCD2 0.78 0.81 1.3 1.04     SCD3 0.59 0.58 1.01 0.76
No statistical analyses for this end point

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of SCD1, SCD2 and SCD3 (overall) Top of page

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of primary case definition (PCD), by centers and across centers Top of page
End point title	Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of primary case definition (PCD), by centers and across centers [5]
End point description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented by center and across centers.
End point type	Secondary
End point timeframe	From Month 2.5 up to study End (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)
Notes [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2336 2007 2276 2306 1985 2005 Units: events per person-year number (not applicable)     PCD – Kilifi 0.08 0.04 0.02 0.03 0.06 0.04     PCD – Korogwe 0.1 0.09 0.04 0.05 0.05 0.07     PCD – Lambarene 0.23 0.17 0.15 0.15 0.1 0.18     PCD – Bagamoyo 0.27 0.15 0.16 0.21 0.08 0.11     PCD – Lilongwe 0.23 0.42 0.09 0.2 0.25 0.29     PCD – Agogo 1.01 0.84 0.59 0.73 0.59 0.77     PCD – Kombewa 1.64 1.62 1.26 1.37 1.37 1.37     PCD – Kintampo 1.71 1.69 1.11 1.31 1.65 1.71     PCD – Manhica 0 0.2 0 0 0.18 0.14     PCD – Nanoro 2.69 3.14 1.95 2.18 2.59 2.79     PCD – Siaya 3.15 3.12 2.09 2.55 2.43 2.67     PCD – Across 1.14 1.08 0.79 0.9 0.86 0.95
No statistical analyses for this end point

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of primary case definition (PCD), by centers and across centers Top of page

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1), across centers Top of page
End point title	Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1), across centers [6]
End point description	CPFMI of SCD1 = malaria episode with PFAP >0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.
End point type	Secondary
End point timeframe	From Month 2.5 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)
Notes [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2336 2007 2276 2306 1985 2005 Units: events per person-year     number (not applicable) 1.81 1.61 1.26 1.41 1.29 1.43
No statistical analyses for this end point

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1), across centers Top of page

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1), across centers Top of page
End point title	Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1), across centers [7]
End point description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP >0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.
End point type	Secondary
End point timeframe	From Booster at Month 20 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)
Notes [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2050 1762 2017 2057 1743 1788 Units: events per person-year number (not applicable)     PCD 1.1 1.23 0.87 1.03 1.01 1.21     SCD1 1.82 1.8 1.39 1.65 1.48 1.79
No statistical analyses for this end point

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1), across centers Top of page

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of PCD and SCD1, across centers Top of page
End point title	Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of PCD and SCD1, across centers [8]
End point description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.
End point type	Secondary
End point timeframe	From Month 33 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)
Notes [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 1864 1546 1784 1838 1516 1548 Units: events per person-year number (not applicable)     PCD 1.1 1.29 1.01 1.1 1.18 1.31     SCD1 1.88 1.91 1.61 1.79 1.73 1.92
No statistical analyses for this end point

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of PCD and SCD1, across centers Top of page

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of PCD, by center and across centers Top of page
End point title	Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of PCD, by center and across centers [9]
End point description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented by center and across centers.
End point type	Secondary
End point timeframe	From Month 2.5 to Month 32
Notes [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2336 2007 2276 2306 1985 2005 Units: events per person-year number (not applicable)     PCD – Kilifi 0.09 0.05 0.03 0.04 0.06 0.04     PCD – Korogwe 0.08 0.06 0.04 0.03 0.02 0.06     PCD – Lambarene 0.21 0.18 0.14 0.14 0.1 0.18     PCD – Bagamoyo 0.31 0.15 0.13 0.19 0.08 0.11     PCD – Lilongwe 0.29 0.47 0.11 0.22 0.27 0.32     PCD – Agogo 1.15 0.86 0.59 0.75 0.56 0.72     PCD – Kombewa 1.67 1.55 1.12 1.29 1.28 1.25     PCD – Kintampo 1.87 1.6 1.08 1.17 1.52 1.6     PCD – Manhica 0 0.15 0 0 0.15 0.12     PCD – Nanoro 2.45 2.92 1.42 1.67 2.27 2.53     PCD – Siaya 3.25 3.09 1.91 2.46 2.41 2.54     PCD – Across 1.15 1.03 0.68 0.81 0.8 0.88
No statistical analyses for this end point

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of PCD, by center and across centers Top of page

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1) Top of page
End point title	Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1) [10]
End point description	CPFMI of SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T).
End point type	Secondary
End point timeframe	From Month 2.5 to Month 32
Notes [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2336 2007 2276 2306 1985 2005 Units: events per person-year     number (not applicable) 1.78 1.54 1.1 1.24 1.19 1.33
No statistical analyses for this end point

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1) Top of page

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1) Top of page
End point title	Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1) [11]
End point description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T).
End point type	Secondary
End point timeframe	From Booster at Month 20 up to Month 32
Notes [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2050 1762 2017 2057 1743 1788 Units: events per person-year number (not applicable)     PCD 1.1 1.2 0.72 0.96 0.91 1.15     SCD1 1.74 1.74 1.14 1.48 1.35 1.72
No statistical analyses for this end point

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1) Top of page

Secondary: Percentage of subjects with severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3, across centers Top of page
End point title	Percentage of subjects with severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3, across centers
End point description	SPFMI of PCD = PFMI > 5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI >5000 parasites/μL and with one or more severity marker. SPFMI of SCD2 = PFMI >0 with one or more severity marker and without co-morbidity diagnosis. SPFMI of SCD3 = PFMI >5000 parasites/μL, with one or more severity marker, and without co-morbidity or HIV. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia < 2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l < 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. Analysis was performed in a pooled manner across age categories. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.
End point type	Secondary
End point timeframe	From Month 2.5 up to the time when 250 subjects were diagnosed with severe malaria of PCD, SCD1, SCD2 and SCD3 (up to the Month 14 time point for each age category or date of booster dose, whichever occurred first)
End point values GSK257049 Group Comparator Group Number of subjects analysed 8597 4364 Units: Percentage of subjects number (not applicable)     PCD 0.019 0.03     SCD1 0.023 0.036     SCD2 0.023 0.034     SCD3 0.019 0.03
No statistical analyses for this end point

Secondary: Percentage of subjects with severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3, across centers Top of page

Secondary: Percentage of subjects with severe PFMI (SPFMI) of PCD and SCD1. Top of page
End point title	Percentage of subjects with severe PFMI (SPFMI) of PCD and SCD1.
End point description	SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category.
End point type	Secondary
End point timeframe	From Month 2.5 to Month 14
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 2830 3995 1466 2008 Units: Percentage of subjects number (not applicable)     SPFMI PCD 2.0 1.5 3.8 2.3     SPFMI SCD1 2.6 1.6 4.9 2.5
No statistical analyses for this end point

Secondary: Percentage of subjects with severe PFMI (SPFMI) of PCD and SCD1. Top of page

Secondary: Percentage of subjects with severe PFMI (SPFMI) of PCD and SCD1 . Top of page
End point title	Percentage of subjects with severe PFMI (SPFMI) of PCD and SCD1 .
End point description	SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category.
End point type	Secondary
End point timeframe	From Month 2.5 to Month 20 at Booster
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 4557 3996 2328 2007 Units: Percentage of subjects number (not applicable)     SPFMI PCD 0.03 0.03 0.04 0.03     SPFMI SCD1 0.03 0.03 0.05 0.03
No statistical analyses for this end point

Secondary: Percentage of subjects with severe PFMI (SPFMI) of PCD and SCD1 . Top of page

Secondary: Percentage of subjects with severe PFMI (SPFMI) of PCD and SCD1 Top of page
End point title	Percentage of subjects with severe PFMI (SPFMI) of PCD and SCD1 [12]
End point description	SPFMI of PCD = PFMI >5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI >5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI >5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL.
End point type	Secondary
End point timeframe	From Month 2.5, from Month 20(booster), from Month 33 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17M age category and of 38 months post-Dose 1 for 6-12W age category) and from Month 2.5 to Month 32 and from Month 20 to Month 32
Notes [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2336 2007 2276 2306 1985 2005 Units: Percentage of subjects number (not applicable)     PCD, M2.5 to SE 0.06 0.05 0.04 0.06 0.04 0.04     PCD, M20 to SE 0.02 0.03 0.03 0.04 0.02 0.03     PCD, M33 to SE 0.01 0.01 0.01 0.02 0.01 0.01     PCD, M2.5 to M32 0.05 0.04 0.03 0.05 0.04 0.04     PCD, M20 to M32 0.02 0.02 0.02 0.02 0.01 0.02     SCD1, M2.5 to SE 0.07 0.06 0.05 0.07 0.04 0.05     SCD1, M20 to SE 0.03 0.03 0.03 0.04 0.02 0.03     SCD1, M33 to SE 0.01 0.01 0.01 0.02 0.01 0.01     SCD1, M2.5 to M32 0.06 0.05 0.04 0.06 0.04 0.04     SCD1, M20 to M32 0.02 0.02 0.02 0.03 0.01 0.02
No statistical analyses for this end point

Secondary: Percentage of subjects with severe PFMI (SPFMI) of PCD and SCD1 Top of page

Secondary: Percentage of subjects with incident severe anaemia (ISA) and malaria hospitalization (MH) for case definitions (CD) considered Top of page
End point title	Percentage of subjects with incident severe anaemia (ISA) and malaria hospitalization (MH) for case definitions (CD) considered
End point description	CD considered were CD1 for ISA and CD1 and CD2 for MH. ISA of CD1 was defined as a documented hemoglobin < 5.0 g/dL identified at clinical presentation to morbidity surveillance system in association with a P. falciparum parasitemia > 5000 parasites/μL. MH of CD1 was defined as a medical hospitalization with confirmed P. falciparum > 5000 parasites/μL. MH of CD2 was defined as a hospitalization which, in the judgment of the principal investigator, P. falciparum infection was the sole or a major contributing factor to the presentation. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.
End point type	Secondary
End point timeframe	From Month 2.5 to Month 20
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 4557 3996 2328 2007 Units: Percentage of subjects number (not applicable)     ISA CD1 0.01 0.01 0.01 0.01     MH CD1 0.05 0.04 0.09 0.05     MH CD2 0.06 0.05 0.1 0.06
No statistical analyses for this end point

Secondary: Percentage of subjects with incident severe anaemia (ISA) and malaria hospitalization (MH) for case definitions (CD) considered Top of page

Secondary: Percentage of subjects with incident severe anaemia (ISA), malaria hospitalization (MH) and fatal malaria (FM) for case definitions (CD) considered. Top of page
End point title	Percentage of subjects with incident severe anaemia (ISA), malaria hospitalization (MH) and fatal malaria (FM) for case definitions (CD) considered. [13]
End point description	ISA CD considered were CD1, CD2 and CD3 (definitions mentioned in the previous outcome measure). MH CD considered were CD1 and CD2 (definitions mentioned in the previous outcome measure).FM CD considered were primary CD (PCD) and sedondary CDs 1 and 4 (SCD1 and SCD4). FM of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease with a fatal outcome. FM of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease with a fatal outcome. FM of SCD4 was defined as a fatal case associated with International Classification Disease (ICD10) codes B50, B53 and/or B54. Code B50 corresponds to P. falciparum malaria including mixed infections of P. falciparum with any other Plasmodium species; Code B53 corresponds to other parasitologically confirmed malaria; Code B54 corresponds to unspecified malaria including clinically diagnosed malaria without parasitological confirmation.
End point type	Secondary
End point timeframe	From Month 2.5 to up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)
Notes [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2336 2007 2276 2306 1985 2005 Units: Percentage of subjects number (not applicable)     ISA CD1 0.02 0.02 0.01 0.01 0.01 0.01     ISA CD2 0.02 0.02 0.01 0.02 0.01 0.02     ISA CD3 0.02 0.03 0.02 0.02 0.02 0.03     MH CD1 0.12 0.08 0.07 0.1 0.06 0.07     MH CD2 0.13 0.1 0.09 0.11 0.08 0.09     FM PCD 0 0 0 0 0 0     FM SCD1 0 0 0 0 0 0     FM SCD4 0 0 0 0 0 0.01
No statistical analyses for this end point

Secondary: Percentage of subjects with incident severe anaemia (ISA), malaria hospitalization (MH) and fatal malaria (FM) for case definitions (CD) considered. Top of page

Secondary: Percentage of subjects with incident severe anaemia (ISA), malaria hospitalization (MH) and fatal malaria (FM) for case definitions (CD) considered Top of page
End point title	Percentage of subjects with incident severe anaemia (ISA), malaria hospitalization (MH) and fatal malaria (FM) for case definitions (CD) considered [14]
End point description	ISA CD considered were CD1, CD2 and CD3 (definitions mentioned in the previous outcome measure). MH CD considered were CD1 and CD2 (definitions mentioned in the previous outcome measure).FM CD considered were primary CD (PCD) and sedondary CDs 1 and 4 (SCD1 and SCD4). FM of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease with a fatal outcome. FM of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease with a fatal outcome. FM of SCD4 was defined as a fatal case associated with International Classification Disease (ICD10) codes B50, B53 and/or B54. Code B50 corresponds to P. falciparum malaria including mixed infections of P. falciparum with any other Plasmodium species; Code B53 corresponds to other parasitologically confirmed malaria; Code B54 corresponds to unspecified malaria including clinically diagnosed malaria without parasitological confirmation.
End point type	Secondary
End point timeframe	From Month 2.5 to Month 32
Notes [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2336 2007 2276 2306 1985 2005 Units: Percentage of subjects number (not applicable)     ISA CD1 0.01 0.01 0.01 0.01 0.1 0.01     ISA CD2 0.02 0.01 0.01 0.01 0.01 0.01     ISA CD3 0.02 0.02 0.01 0.02 0.02 0.02     MH CD1 0.11 0.07 0.06 0.09 0.05 0.06     MH CD2 0.12 0.09 0.08 0.1 0.07 0.08     FM PCD 0 0 0 0 0 0     FM SCD1 0 0 0 0 0 0     FM SCD4 0 0 0 0 0 0
No statistical analyses for this end point

Secondary: Percentage of subjects with incident severe anaemia (ISA), malaria hospitalization (MH) and fatal malaria (FM) for case definitions (CD) considered Top of page

Secondary: Percentage of subjects with prevalent parasitemia, prevalent gametocytemia and prevalent severe and moderate anemia Top of page
End point title	Percentage of subjects with prevalent parasitemia, prevalent gametocytemia and prevalent severe and moderate anemia
End point description	Prevalent parasitemia (PP) was defined as a documented P. falciparum asexual parasite density > 0 identified at timing of assessment. Prevalent gametocytemia (PG) was defined as a documented P. falciparum gametocyte density > 0 identified at a cross sectional survey. Prevalent severe anemia (PSA) was defined as a documented hemoglobin < 5.0 g/dL identified at timing of assessment. Prevalent moderate anemia (PMA) was defined as a documented hemoglobin < 8.0 g/dL identified at at timing of assessment. Results presented are uncorrected for the double enrollment of one subject receiving RTS,S/AS01.
End point type	Secondary
End point timeframe	At Month 20 (Booster)
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 4140 3571 2100 1766 Units: Percentage of subjects number (not applicable)     PP 0.07 0.07 0.11 0.08     PSA 0 0 0 0     PMA 0.03 0.04 0.03 0.04     PG 0.03 0 0.04 0
No statistical analyses for this end point

Secondary: Percentage of subjects with prevalent parasitemia, prevalent gametocytemia and prevalent severe and moderate anemia Top of page

Secondary: Percentage of subjects with prevalent parasitemia and prevalent severe and moderate anemia Top of page
End point title	Percentage of subjects with prevalent parasitemia and prevalent severe and moderate anemia [15]
End point description	Prevalent parasitemia (PP) was defined as a documented P. falciparum asexual parasite density > 0 identified at timing of assessment. Prevalent severe anemia (PSA) was defined as a documented hemoglobin < 5.0 g/dL identified at timing of assessment. Prevalent moderate anemia (PMA) was defined as a documented hemoglobin < 8.0 g/dL identified at timing of assessment. Analysis was performed on subjects aged 5-17 months at enrollment. Study End (Early) corresponds to children whose Month 32 visit took place after 30 June 2012 and who had one cross-sectional visit at study end. These children’s last study visit was relatively earlier, with a median follow-up time of 14 months post Month 32. Study End (Late) corresponds to children whose Month 32 visit took place before (and including) 30 June 2012, and who had 2 cross-sectional visits after Month 32. These children’s last study visit was relatively later, with a median follow-up time of 17 months post Month 32).
End point type	Secondary
End point timeframe	At Months 32, 44, at study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category) (early and late)
Notes [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 1979 1648 1935 1967 1637 1656 Units: Percentage of subjects number (not applicable)     PP, Month 32 0.14 0.1 0.09 0.1 0.09 0.11     PSA, Month 32 0 0 0 0 0 0     PMA, Month 32 0.02 0.03 0.02 0.02 0.02 0.04     PP, Month 44 0.2 0 0.16 0.17 0 0     PSA, Month 44 0 0 0 0 0 0     PMA, Month 44 0.01 0 0.01 0.02 0 0     PP, SE (Early) 0.14 0.13 0.09 0.1 0.11 0.14     PSA, SE (Early) 0 0 0 0 0 0     PMA, SE (Early) 0.03 0.03 0.01 0.02 0.03 0.03     PP, SE (Late) 0.21 0 0.18 0.18 0 0     PSA, SE (Late) 0 0 0 0 0 0     PMA, SE (Late) 0.02 0 0.03 0.03 0 0
No statistical analyses for this end point

Secondary: Percentage of subjects with prevalent parasitemia and prevalent severe and moderate anemia Top of page

Secondary: Percentage of subjects with pneumonia, all-cause hospitalization and sepsis, as per case definitions assessed Top of page
End point title	Percentage of subjects with pneumonia, all-cause hospitalization and sepsis, as per case definitions assessed
End point description	Pneumonia case definitions assessed are PCD and SCD 1, 2 and 3. Pneumonia of PCD was defined as cough or difficulty breathing AND tachypnea (≥ 50 breaths per minute < 1 year, ≥ 40 breaths per minute ≥ 1year) AND lower chest wall indrawing. Pneumonia of SCD1 was defined as pneumonia of PCD accompanied by chest X-ray (CXR) consolidation or pleural effusion on x-ray taken within 72 h of admission. Pneumonia of SCD2 was defined as pneumonia of PCD accompanied by consolidation or pleural effusion or other infiltrates on a chest x-ray taken within 72 h of admission. Pneumonia of SCD3 was defined as pneumonia of PCD accompanied by an oxygen saturation < 90%. All-cause hospitalization of PCD was defined as a medical hospitalization of any cause (excludes planned admissions for medical investigation/care or elective surgery and trauma). Sepsis cases were defined as a child with positive blood culture (CD1) or salmonella blood culture (CD2).
End point type	Secondary
End point timeframe	From Month 2.5 to Month 20
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 4557 3996 2328 2007 Units: Percentage of subjects number (not applicable)     Pneumonia PCD 0.03 0.04 0.03 0.04     Pneumonia SCD1 0.01 0.01 0 0.01     Pneumonia SCD2 0.02 0.03 0.02 0.03     Pneumonia SCD3 0 0.01 0.01 0.01     All-Cause Hospitalization PCD 0.15 0.18 0.19 0.19     Sepsis CD1 0.02 0.02 0.02 0.01     Sepsis CD2 0.01 0.01 0.01 0.01
No statistical analyses for this end point

Secondary: Percentage of subjects with pneumonia, all-cause hospitalization and sepsis, as per case definitions assessed Top of page

Secondary: Percentage of subjects with fatal malaria (FM) and all-cause mortality (ACM) as per case definitions assessed Top of page
End point title	Percentage of subjects with fatal malaria (FM) and all-cause mortality (ACM) as per case definitions assessed
End point description	Fatal malaria case definitions assessed were PCD and SCD1. Fatal malaria of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease (defined in a previous outcome measure) with a fatal outcome. Fatal malaria of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease (defined previously) with a fatal outcome. All-cause mortality case definitions assessed were the case definitions (CD) 1 and 2. All-cause mortality of CD1 was defined as a fatality (of any cause) (including mortality in the community and in hospital). All-cause mortality of CD2 was defined as a fatality (medical cause) (including mortality in the community and in hospital), at the exclusion of trauma which may be diagnosed by verbal autopsy. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.
End point type	Secondary
End point timeframe	From Month 2.5 to Month 20
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 4557 3996 2328 2007 Units: Percentage of subjects number (not applicable)     Fatal Malaria PCD 0 0 0 0     Fatal Malaria SCD1 0 0 0 0     All-cause mortality CD1 0.01 0.01 0.01 0.01     All-cause mortality CD2 0.01 0.01 0.01 0.01
No statistical analyses for this end point

Secondary: Percentage of subjects with fatal malaria (FM) and all-cause mortality (ACM) as per case definitions assessed Top of page

Secondary: Percentage of subjects with pneumonia, all-cause hospitalization/mortality and sepsis, as per case definitions assessed Top of page
End point title	Percentage of subjects with pneumonia, all-cause hospitalization/mortality and sepsis, as per case definitions assessed [16]
End point description	Pneumonia of PCD was defined as cough or difficulty breathing (on history) AND tachypnea (>= 50 breaths per minute < 1 year, >= 40 breaths per minute >= 1year) AND lower chest wall indrawing,SCD1 was defined as pneumonia of PCD accompanied by chest X-ray (CXR) consolidation or pleural effusion on x-ray taken within 72 h of admission,SCD2 was defined as pneumonia of PCD accompanied by consolidation or pleural effusion or other infiltrates on a chest x-ray taken within 72 h of admission,SCD3 was defined as pneumonia of PCD accompanied by an oxygen saturation less than 90%.All-cause hospitalization of PCD was defined as a medical hospitalization of any cause (excluding planned admissions for medical investigation/care or elective surgery and trauma).All-cause mortality of CD1 was defined as a fatality (of any cause),of CD2 defined as a fatality (medical cause).Sepsis of CD1 was defined as a child with positive blood culture;CD2 defined as a child with positive salmonella blood culture.
End point type	Secondary
End point timeframe	From Month 2.5 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)
Notes [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2336 2007 2276 2306 1985 2005 Units: Percentage of subjects number (not applicable)     All-Cause Hospitalization PCD 0.24 0.24 0.21 0.22 0.23 0.23     Sepsis CD1 0.03 0.02 0.02 0.02 0.02 0.02     Sepsis CD2 0.02 0.01 0.01 0.01 0.01 0.02     Pneumonia PCD 0.03 0.05 0.04 0.03 0.05 0.05     Pneumonia SCD1 0.01 0.01 0.01 0.01 0.01 0.01     Pneumonia SCD2 0.02 0.03 0.03 0.02 0.03 0.03     Pneumonia SCD3 0.01 0.01 0 0 0.01 0.01     All-Cause Mortality CD1 0.01 0.01 0.01 0.01 0.02 0.02     All-Cause Mortality CD2 0.01 0.01 0.01 0.01 0.02 0.02
No statistical analyses for this end point

Secondary: Percentage of subjects with pneumonia, all-cause hospitalization/mortality and sepsis, as per case definitions assessed Top of page

Secondary: Percentage of subjects with blood transfusion, as per case definition assessed Top of page
End point title	Percentage of subjects with blood transfusion, as per case definition assessed [17]
End point description	Blood transfusion case definition assessed was the case definition 1 (CD1). Blood transfusion of CD1 was defined as a child with inpatient admission with documented blood transfusion.
End point type	Secondary
End point timeframe	From Month 2.5 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Notes [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2336 2007 2276 2306 1985 2005 Units: Percentage of subjects     number (not applicable) 0.04 0.04 0.03 0.03 0.03 0.03
No statistical analyses for this end point

Secondary: Percentage of subjects with blood transfusion, as per case definition assessed Top of page

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of primary case definition (PCD), by gender and overall Top of page
End point title	Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of primary case definition (PCD), by gender and overall [18]
End point description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). Analysis was performed on subjects aged 5-17 months and 6-12 weeks at enrollment. Results were presented by gender and overall.
End point type	Secondary
End point timeframe	From Month 2.5 to Month 32
Notes [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2336 2007 2276 2306 1985 2005 Units: events per person-year number (not applicable)     PCD Females 1.11 1.06 0.72 0.8 0.76 0.79     PCD Males 1.19 1.01 0.65 0.81 0.83 0.96     PCD Overall 1.15 1.03 0.68 0.81 0.8 0.88
No statistical analyses for this end point

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of primary case definition (PCD), by gender and overall Top of page

Secondary: Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ). Top of page
End point title	Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ).
End point description	Anthropometry consisted of length/height for age z-score [HAZ] (children < 2 years length measure and children ≥ 2 years standing height measure), weight for age z-score [WAZ] and mid-upper arm circumference for age z-score [MUACZ] measurements, where a HAZ < -1,5 z-score, indicates growth deficit, while a HAZ between -1,0 and ± 1,0 z-score, indicates normal height. A WAZ ≤ -3 z-score indicates a very low weight for age, a WAZ > -3 and ≤ -2 z-score indicates a low weight for age, a WAZ > - 2 z-score indicates normal weight. A MUACZ < -2 z-score indicates children that are wasted, a MUACZ < - 3 z-score indicates severely wasted children.
End point type	Secondary
End point timeframe	At Month 20 (Booster)
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 5948 4358 2974 2179 Units: z-score arithmetic mean (standard deviation)     HAZ -1.6 ± 1 -1.7 ± 1.1 -1.6 ± 1 -1.7 ± 1.2     WAZ -1 ± 1 -0.9 ± 1 -1 ± 1 -0.9 ± 1     MUACZ -0.3 ± 0.9 -0.1 ± 1 -0.3 ± 0.9 -0.1 ± 1
No statistical analyses for this end point

Secondary: Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ). Top of page

Secondary: Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ) Top of page
End point title	Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ) [19]
End point description	Anthropometry consisted of length/height for age z-score [HAZ] (children < 2 years length measure and children ≥ 2 years standing height measure), weight for age z-score [WAZ] and mid-upper arm circumference for age z-score [MUACZ] measurements, where a HAZ < -1,5 z-score, indicates growth deficit, while a HAZ between -1,0 and ± 1,0 z-score, indicates normal height. A WAZ ≤ -3 z-score indicates a very low weight for age, a WAZ > -3 and ≤ -2 z-score indicates a low weight for age, a WAZ > - 2 z-score indicates normal weight. A MUACZ < -2 z-score indicates children that are wasted, a MUACZ < - 3 z-score indicates severely wasted children. Note: The early study end refers to children whose last visit in the primary study phase (Month 32) was after 30 June 2012 and who by protocol had one cross-sectional study end and to late study end refers to children whose last visit in the primary study phase (Month 32) was after 30 June 2012 and who by protocol had one cross-sectional study end.
End point type	Secondary
End point timeframe	At Months 32, 44, at study end (early and late) (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Notes [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2392 1725 2363 2382 1726 1731 Units: z-score arithmetic mean (standard deviation)     HAZ, Month 32 -1.4 ± 1.0 -1.5 ± 1.1 -1.3 ± 1.0 -1.4 ± 1.0 -1.5 ± 1.1 -1.4 ± 1.1     WAZ, Month 32 -1.0 ± 0.9 -0.9 ± 1.0 -0.9 ± 0.9 -1.0 ± 0.9 -0.9 ± 1.0 -0.9 ± 1.0     MUACZ, Month 32 -0.4 ± 0.8 -0.4 ± 1.0 -0.4 ± 0.9 -0.4 ± 0.9 -0.4 ± 0.9 -0.3 ± 1.0     HAZ, Month 44 -1.2 ± 1.0 0 ± 0 -1.1 ± 1.0 -1.2 ± 0.9 0 ± 0 0 ± 0     WAZ, Month 44 -0.9 ± 0.8 0 ± 0 -0.9 ± 0.9 -1.0 ± 0.9 0 ± 0 0 ± 0     MUACZ, Month 44 -0.6 ± 0.8 0 ± 0 -0.7 ± 0.8 -0.7 ± 0.9 0 ± 0 0 ± 0     HAZ, Study end Early -1.3 ± 1.0 -1.4 ± 1.0 -1.3 ± 1.0 -1.3 ± 1.0 -1.4 ± 1.0 -1.4 ± 1.0     WAZ, Study end Early -1.0 ± 0.8 -0.9 ± 0.9 -1.0 ± 0.8 -1.0 ± 0.8 -0.9 ± 0.9 -0.9 ± 0.9     MUACZ, Study end Early -0.8 ± 0.8 -0.5 ± 0.9 -0.8 ± 0.9 -0.8 ± 0.9 -0.5 ± 0.9 -0.4 ± 0.9     HAZ, Study end Late -1.1 ± 1.0 0 ± 0 -1.0 ± 0.9 -1.1 ± 0.9 0 ± 0 0 ± 0     WAZ, Study end Late -1.0 ± 0.8 0 ± 0 -0.9 ± 0.9 -1.0 ± 0.9 0 ± 0 0 ± 0     MUACZ, Study end Late -0.7 ± 0.8 0 ± 0 -0.7 ± 0.8 -0.8 ± 0.9 0 ± 0 0 ± 0
No statistical analyses for this end point

Secondary: Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ) Top of page

Secondary: Antibody concentrations against Plasmodium falciparum circumsporozoite (anti-CS) Top of page
End point title	Antibody concentrations against Plasmodium falciparum circumsporozoite (anti-CS)
End point description	Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were assessed for the first 200 subjects enrolled in each study center.
End point type	Secondary
End point timeframe	At Day 0 and at Month 3
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 1036 1234 529 627 Units: EL.U/mL geometric mean (confidence interval 95%)     Anti-CS, Day 0 0.3 (0.3 to 0.3) 0.4 (0.4 to 0.4) 0.3 (0.3 to 0.3) 0.4 (0.4 to 0.5)     Anti-CS, Month 3 621 (591.5 to 651.9) 210.5 (198.2 to 223.6) 0.3 (0.3 to 0.3) 0.3 (0.3 to 0.3)
No statistical analyses for this end point

Secondary: Antibody concentrations against Plasmodium falciparum circumsporozoite (anti-CS) Top of page

Secondary: Antibody concentrations against P. falciparum circumsporozoite (anti-CS). Top of page
End point title	Antibody concentrations against P. falciparum circumsporozoite (anti-CS).
End point description	Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were assessed for the first 200 HIV-infected subjects enrolled in each study center. HIV infection was confirmed if present at screening or identified by morbidity surveillance, not infection confirmed by antibody testing after 18 months of age or by PCR, by the time of the analysis of results up to the Month 14 time point for the respective 5-17 months and 6-12 weeks age categories.
End point type	Secondary
End point timeframe	At Day 0 and at Month 3
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 29 25 17 5 Units: EL.U/mL geometric mean (confidence interval 95%)     Anti-CS, Day 0 0.3 (0.2 to 0.5) 0.3 (0.2 to 0.4) 0.4 (0.3 to 0.5) 0.3 (0.3 to 0.3)     Anti-CS, Month 3 264.7 (137.5 to 509.6) 125.3 (58.1 to 270.3) 0.5 (0.2 to 1.7) 0.3 (0.3 to 0.3)
No statistical analyses for this end point

Secondary: Antibody concentrations against P. falciparum circumsporozoite (anti-CS). Top of page

Secondary: Antibody concentrations against P. falciparum circumsporozoite (anti-CS) . Top of page
End point title	Antibody concentrations against P. falciparum circumsporozoite (anti-CS) . [20]
End point description	Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL.
End point type	Secondary
End point timeframe	At Months 20, 21 and 32
Notes [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 426 554 442 438 530 569 Units: EL.U/mL geometric mean (confidence interval 95%)     Anti-CS, Agogo - Month 20 0.3 (0.3 to 0.4) 0.3 (0.2 to 0.3) 34.1 (24.0 to 48.3) 52.1 (41.3 to 65.7) 5.1 (3.4 to 7.6) 5.6 (3.8 to 8.4)     Anti-CS, Agogo - Month 21 0.3 (0.2 to 0.3) 0.3 (0.2 to 0.3) 265.0 (220.9 to 317.9) 48.3 (37.6 to 61.9) 137.6 (95.0 to 199.3) 5.3 (3.5 to 8.0)     Anti-CS, Agogo - Month 32 0.3 (0.2 to 0.3) 0.3 (0.3 to 0.4) 46.3 (34.8 to 61.6) 28.8 (21.8 to 37.9) 14.8 (9.5 to 23.1) 2.9 (1.9 to 4.5)     Anti-CS, Bagamoyo - Month 20 0.3 (0.3 to 0.3) 0.3 (0.2 to 0.3) 26.6 (14.2 to 49.9) 23.1 (11.1 to 47.8) 6.9 (4.8 to 10.0) 7.6 (5.1 to 11.4)     Anti-CS, Bagamoyo - Month 21 0.6 (0.2 to 1.4) 0.3 (0.2 to 0.4) 306.6 (206.5 to 455.4) 31.8 (19.4 to 52.2) 169.9 (129.8 to 222.5) 7.2 (4.5 to 11.6)     Anti-CS, Bagamoyo - Month 32 0.3 (0.3 to 0.3) 0.3 (0.3 to 0.3) 44.6 (27.2 to 73.3) 16.9 (10.2 to 27.9) 14.4 (9.6 to 21.7) 3.7 (2.4 to 5.7)     Anti-CS, Kilifi - Month 20 0.3 (0.3 to 0.3) 0.3 (0.2 to 0.3) 34.3 (26.3 to 44.7) 33.1 (26.3 to 41.6) 6.6 (4.6 to 9.6) 6.1 (4.0 to 9.4)     Anti-CS, Kilifi - Month 21 0.3 (0.3 to 0.3) 0.3 (0.3 to 0.3) 308.4 (251.8 to 377.7) 24.3 (18.1 to 32.8) 229.3 (175.4 to 299.9) 5.3 (3.4 to 8.2)     Anti-CS, Kilifi - Month 32 0.3 (0.2 to 0.4) 0.3 (0.3 to 0.3) 59.4 (45.7 to 77.2) 14.9 (11.0 to 20.2) 19.8 (14.1 to 27.8) 2.8 (1.8 to 4.4)     Anti-CS, Kintampo - Month 20 0.4 (0.3 to 0.5) 0.3 (0.3 to 0.4) 50.8 (37.2 to 69.5) 36.6 (26.4 to 50.7) 3.8 (2.5 to 5.8) 3.7 (2.5 to 5.6)     Anti-CS, Kintampo - Month 21 0.3 (0.2 to 0.3) 0.3 (0.3 to 0.4) 266.8 (188.9 to 377.0) 41.2 (31.2 to 54.6) 128.8 (95.7 to 173.4) 3.2 (2.0 to 5.0)     Anti-CS, Kintampo - Month 32 0.4 (0.3 to 0.5) 0.3 (0.3 to 0.3) 70.9 (55.2 to 90.9) 20.2 (14.3 to 28.5) 13.3 (8.1 to 21.9) 2.2 (1.4 to 3.4)     Anti-CS, Kombewa - Month 20 0.3 (0.3 to 0.4) 0.4 (0.3 to 0.5) 39.8 (29.9 to 53.0) 46.6 (33.2 to 65.3) 5.5 (3.6 to 8.4) 8.7 (5.8 to 13.0)     Anti-CS, Kombewa - Month 21 0.4 (0.3 to 0.4) 0.4 (0.3 to 0.5) 308.5 (252.4 to 377.0) 37.1 (26.7 to 51.5) 146.3 (96.6 to 221.6) 9.2 (6.0 to 14.2)     Anti-CS, Kombewa - Month 32 0.3 (0.3 to 0.4) 0.4 (0.3 to 0.4) 53.8 (40.3 to 71.7) 19.8 (14.1 to 27.7) 8.3 (4.8 to 14.3) 4.3 (2.8 to 6.6)     Anti-CS, Korogwe - Month 20 0.3 (0.3 to 0.3) 0.3 (0.2 to 0.3) 29.4 (21.4 to 40.4) 28.2 (22.5 to 35.3) 7.9 (5.3 to 11.8) 8.1 (5.2 to 12.7)     Anti-CS, Korogwe - Month 21 0.3 (0.2 to 0.3) 0.3 (0.2 to 0.4) 305.6 (266.4 to 350.5) 27.1 (20.7 to 35.5) 178.3 (141.2 to 225.1) 7.6 (4.8 to 11.9)     Anti-CS, Korogwe - Month 32 0.3 (0.2 to 0.3) 0.3 (0.2 to 0.3) 47.4 (37.5 to 59.9) 16.8 (13.1 to 21.7) 19.6 (13.0 to 29.6) 4.9 (3.0 to 7.9)     Anti-CS, Lambarene - Month 20 0.3 (0.2 to 0.3) 0.3 (0.3 to 0.3) 8.2 (5.8 to 11.6) 11.1 (7.0 to 17.6) 7.7 (5.1 to 11.6) 8.3 (5.8 to 12.1)     Anti-CS, Lambarene - Month 21 0.3 (0.2 to 0.3) 0.3 (0.2 to 0.3) 203.6 (155.1 to 267.3) 10.6 (6.6 to 16.8) 251.3 (184.8 to 341.7) 7.4 (5.0 to 10.8)     Anti-CS, Lambarene - Month 32 0.3 (0.2 to 0.4) 0.3 (0.2 to 0.3) 23.0 (15.6 to 33.9) 5.9 (3.6 to 9.9) 21.0 (13.9 to 31.7) 4.1 (2.9 to 5.8)     Anti-CS, Lilongwe - Month 20 0.4 (0.2 to 0.7) 0.3 (0.3 to 0.4) 45.9 (28.6 to 73.8) 22.2 (11.2 to 44.0) 5.1 (3.2 to 8.3) 7.4 (4.7 to 11.5)     Anti-CS, Lilongwe - Month 21 0.3 (0.2 to 0.4) 0.3 (0.2 to 0.4) 285.0 (228.5 to 355.4) 17.0 (8.1 to 35.7) 126.1 (92.7 to 171.5) 8.0 (5.2 to 12.1)     Anti-CS, Lilongwe - Month 32 0.3 (0.2 to 0.4) 0.3 (0.2 to 0.3) 45.6 (28.8 to 72.3) 12.7 (6.4 to 25.3) 15.4 (9.3 to 25.4) 4.5 (3.1 to 6.6)     Anti-CS, Nanoro - Month 20 0.3 (0.3 to 0.3) 0.3 (0.3 to 0.4) 57.2 (43.4 to 75.4) 61.8 (46.3 to 82.4) 2.7 (1.7 to 4.4) 3.2 (2.1 to 4.7)     Anti-CS, Nanoro - Month 21 0.3 (0.2 to 0.3) 0.3 (0.3 to 0.4) 520.5 (443.4 to 611.1) 71.1 (54.8 to 92.3) 163.2 (121.4 to 219.4) 3.1 (2.0 to 4.6)     Anti-CS, Nanoro - Month 32 0.3 (0.3 to 0.3) 0.5 (0.4 to 0.6) 69.2 (55.2 to 86.9) 35.0 (25.7 to 47.9) 11.9 (7.4 to 19.2) 2.8 (2.0 to 4.0)     Anti-CS, Siaya - Month 20 0.3 (0.3 to 0.4) 0.4 (0.3 to 0.5) 28.4 (18.4 to 44.0) 32.8 (21.6 to 50.1) 7.0 (4.2 to 11.5) 8.9 (5.5 to 14.2)     Anti-CS, Siaya - Month 21 0.3 (0.2 to 0.4) 0.4 (0.3 to 0.5) 398.1 (324.6 to 488.2) 36.4 (22.6 to 58.6) 171.5 (109.8 to 267.9) 8.4 (5.2 to 13.6)     Anti-CS, Siaya - Month 32 0.4 (0.3 to 0.5) 0.5 (0.4 to 0.7) 55.8 (41.4 to 75.3) 21.7 (13.4 to 35.1) 23.6 (14.2 to 39.1) 5.5 (3.3 to 9.2)     Anti-CS, Manhica - Month 20 0 (0 to 0) 0.3 (0.3 to 0.3) 0 (0 to 0) 0 (0 to 0) 12.3 (8.4 to 18.1) 14.7 (10.0 to 21.5)     Anti-CS, Manhica - Month 21 0 (0 to 0) 0.3 (0.2 to 0.3) 0 (0 to 0) 0 (0 to 0) 260.2 (176.4 to 383.8) 12.3 (7.7 to 19.5)     Anti-CS, Manhica - Month 32 0 (0 to 0) 0.3 (0.3 to 0.3) 0 (0 to 0) 0 (0 to 0) 25.4 (14.8 to 43.5) 6.8 (4.0 to 11.5)     Anti-CS, Overall sites - Month 20 0.3 (0.3 to 0.3) 0.3 (0.3 to 0.3) 34.4 (30.7 to 38.6) 35.4 (31.7 to 39.5) 5.9 (5.2 to 6.7) 6.6 (5.8 to 7.5)     Anti-CS, Overall sites - Month 21 0.3 (0.3 to 0.3) 0.3 (0.3 to 0.3) 318.2 (295.1 to 343.0) 34.2 (30.5 to 38.3) 169.9 (153.8 to 187.7) 6.2 (5.4 to 7.0)     Anti-CS, Overall sites - Month 32 0.3 (0.3 to 0.3) 0.3 (0.3 to 0.3) 52.4 (47.8 to 57.6) 19.3 (17.2 to 21.8) 15.9 (13.8 to 18.3) 3.7 (3.3 to 4.2)
No statistical analyses for this end point

Secondary: Antibody concentrations against P. falciparum circumsporozoite (anti-CS) . Top of page

Secondary: Antibody concentrations against P. falciparum circumsporozoite (anti-CS) Top of page
End point title	Antibody concentrations against P. falciparum circumsporozoite (anti-CS) [21]
End point description	Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results for this endpoint were assessed for Agogo, Lilongwe and Siaya sites.
End point type	Secondary
End point timeframe	At Month 44 and at study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Notes [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 98 131 104 101 101 103 Units: EL.U/mL geometric mean (confidence interval 95%)     Anti-CS, Agogo - Month 44 0.3 (0.2 to 0.3) 0 (0 to 0) 27.7 (20.1 to 38.1) 17.9 (13.5 to 23.6) 0 (0 to 0) 0 (0 to 0)     Anti-CS, Agogo - Study end 0.3 (0.2 to 0.3) 0.3 (0.2 to 0.4) 23.2 (16.7 to 32.3) 17.2 (12.7 to 23.3) 6.1 (3.2 to 11.4) 2.1 (1.3 to 3.4)     Anti-CS, Lilongwe - Month 44 0.3 (0.2 to 0.3) 0 (0 to 0) 30.5 (21.4 to 43.5) 8.5 (4.5 to 15.9) 0 (0 to 0) 0 (0 to 0)     Anti-CS, Lilongwe - Study end 0.3 (0.3 to 0.3) 0.3 (0.2 to 0.3) 26.9 (18.3 to 39.5) 7.2 (4.1 to 12.5) 10.9 (6.3 to 18.7) 2.8 (1.8 to 4.2)     Anti-CS, Siaya - Month 44 0.5 (0.4 to 0.8) 0 (0 to 0) 41.4 (29.7 to 57.9) 21.2 (14.0 to 32.0) 0 (0 to 0) 0 (0 to 0)     Anti-CS, Siaya - Study end 0.4 (0.3 to 0.6) 0.4 (0.3 to 0.6) 27.4 (19.4 to 38.9) 15.8 (10.2 to 24.4) 10.4 (6.1 to 17.7) 3.3 (1.9 to 5.6)     Anti-CS, Overall - Month 44 0.3 (0.3 to 0.4) 0 (0 to 0) 33.0 (26.9 to 40.3) 16.8 (13.5 to 21.0) 0 (0 to 0) 0 (0 to 0)     Anti-CS, Overall - Study end 0.3 (0.3 to 0.4) 0.3 (0.3 to 0.4) 25.4 (20.6 to 31.2) 14.4 (11.4 to 18.1) 8.9 (6.5 to 12.3) 2.6 (2.0 to 3.4)
No statistical analyses for this end point

Secondary: Antibody concentrations against P. falciparum circumsporozoite (anti-CS) Top of page

Secondary: Antibody concentrations against P. falciparum circumsporozoite (anti-CS), by tertile. Top of page
End point title	Antibody concentrations against P. falciparum circumsporozoite (anti-CS), by tertile.
End point description	Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were presented by tertiles of anti-CS responses in the first 200 participants per site, based on subjects assessed for vaccine efficacy results.
End point type	Secondary
End point timeframe	At Month 3
End point values GSK257049 - Menjugate [5-17M] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 545 639 Units: EL.U/mL geometric mean (confidence interval 95%)     Anti-CS, Tertile 1 264.15 (238.2 to 292.9) 78.45 (69.4 to 88.6)     Anti-CS, Tertile 2 613.79 (598.3 to 629.7) 230.68 (224.7 to 236.8)     Anti-CS, Tertile 3 1351.41 (1276.3 to 1431) 592.65 (557.8 to 629.6)     Anti-CS, Across Tertiles 603.77 (563.6 to 646.8) 220.9 (204.1 to 239)
No statistical analyses for this end point

Secondary: Antibody concentrations against P. falciparum circumsporozoite (anti-CS), by tertile. Top of page

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of primary case definition (PCD), by tertile. Top of page
End point title	Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of primary case definition (PCD), by tertile. [22]
End point description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). RaCPFMI was calculated by tertile of anti-CS response post primary vaccination pooled across sites, on subjects in GSK257049-Menjugate Groups (5-17M; 6-12W) and Comparator Groups (5-17M; 6-12W), taking into account the first 200 participants per site.
End point type	Secondary
End point timeframe	From Month 2.5 to Month 32
Notes [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - Menjugate [5-17M] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 565 677 182 214 Units: events per person-year number (not applicable)     Tertile 1 1.21 0.93 0.68 1.29     Tertile 2 1.21 0.93 0.78 0.7     Tertile 3 1.21 0.93 1.03 0.58
No statistical analyses for this end point

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of primary case definition (PCD), by tertile. Top of page

Secondary: Antibody concentrations against P. falciparum circumsporozoite (anti-CS), by tertile Top of page
End point title	Antibody concentrations against P. falciparum circumsporozoite (anti-CS), by tertile
End point description	Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were presented by tertiles of anti-CS responses in the first 200 participants per site, based on subjects assessed for vaccine efficacy results.
End point type	Secondary
End point timeframe	At Month 21
End point values GSK257049 - GSK257049 [5-17M] Group GSK257049 -GSK257049 [6-12W] Group Number of subjects analysed 465 546 Units: EL.U/mL geometric mean (confidence interval 95%)     Anti-CS, Tertile 1 138.15 (123.5 to 154.5) 47.99 (41.2 to 55.9)     Anti-CS, Tertile 2 311.35 (303.4 to 319.6) 194.85 (189.9 to 200)     Anti-CS, Tertile 3 675.24 (632.8 to 720.5) 479.44 (446.8 to 514.5)     Anti-CS, Across Tertiles 307.93 (286.2 to 331.3) 165.31 (150 to 182.2)
No statistical analyses for this end point

Secondary: Antibody concentrations against P. falciparum circumsporozoite (anti-CS), by tertile Top of page

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of primary case definition (PCD), by tertile Top of page
End point title	Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of primary case definition (PCD), by tertile [23]
End point description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). RaCPFMI was calculated by tertile of anti-CS response post booster vaccination pooled across sites, on subjects in R3R (5-17M; 6-12W) (or R3R below) and C3C (5-17M; 6-12W) (or C3C below) groups taking into account the first 200 participants per site.
End point type	Secondary
End point timeframe	From Booster at Month 20 to Month 32
Notes [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 -GSK257049 [6-12W] Group Number of subjects analysed 479 594 156 420 Units: events per person-year number (not applicable)     Tertile 1 1.21 0.94 0.68 0.99     Tertile 2 1.21 0.94 0.68 0.84     Tertile 3 1.21 0.94 0.77 0.64
No statistical analyses for this end point

Secondary: Rate of all episodes of clinical P. falciparum malaria infection (CPFMI) of primary case definition (PCD), by tertile Top of page

Secondary: Antibody concentrations against Hepatitis B surface antigen (anti-HBs). Top of page
End point title	Antibody concentrations against Hepatitis B surface antigen (anti-HBs).
End point description	Antibody concentrations assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-offs were ≥ 10 and 100 mIU/mL, respectively. Results were assessed for the first 200 subjects in each center.
End point type	Secondary
End point timeframe	At Day 0 and at Month 3
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 1029 1213 526 627 Units: mIU/mL geometric mean (confidence interval 95%)     Anti-HBs, Day 0 166.3 (148 to 186.8) 8.6 (8 to 9.3) 168.6 (142.8 to 199.2) 8.5 (7.7 to 9.4)     Anti-HBs, Month 3 81567.7 (75442.7 to 88189.9) 13674.3 (12811.5 to 14595.3) 127.5 (108.8 to 149.4) 728.8 (643.6 to 825.2)
No statistical analyses for this end point

Secondary: Antibody concentrations against Hepatitis B surface antigen (anti-HBs). Top of page

Secondary: Antibody concentrations against Hepatitis B surface antigen Top of page
End point title	Antibody concentrations against Hepatitis B surface antigen
End point description	Antibody concentrations as assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in mIU/mL. The seropositivity and seroprotection cut-offs were ≥ 10 and 100 mIU/mL, respectively. Results were assessed for the first 200 HIV-infected subjects enrolled in each study center. HIV infection was confirmed if present at screening or identified by morbidity surveillance, not infection confirmed by antibody testing after 18 months of age or by PCR, by the time of the analysis of results up to the Month 14 time point for the respective 5-17 months and 6-12 weeks age categories.
End point type	Secondary
End point timeframe	At Day 0 and at Month 3
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 29 25 17 5 Units: mIU/mL geometric mean (confidence interval 95%)     Anti-HBs, Day 0 98.6 (43.8 to 222) 7.5 (4.8 to 11.6) 63.6 (19.4 to 208.4) 5 (5 to 5)     Anti-HBs, Month 3 37476.5 (17766 to 79054.9) 1996.2 (561.6 to 7095.8) 37.1 (9.1 to 151.9) 197.2 (7.7 to 5081.7)
No statistical analyses for this end point

Secondary: Antibody concentrations against Hepatitis B surface antigen Top of page

Secondary: Antibody concentrations against Hepatitis B surface antigen (anti-HBs) Top of page
End point title	Antibody concentrations against Hepatitis B surface antigen (anti-HBs)
End point description	Antibody concentrations as assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in mIU/mL. The seropositivity and seroprotection cut-offs were ≥ 6.2 and 100 mIU/mL, respectively. Results were assessed for the first 200 subjects in each center.
End point type	Secondary
End point timeframe	At Months 20 and 21
End point values GSK257049 - GSK257049 [5-17M] Group GSK257049 -GSK257049 [6-12W] Group Number of subjects analysed 95 134 Units: mIU/mL geometric mean (confidence interval 95%)     Anti-HBs, Month 20 5068.5 (3711.3 to 6922) 1532.5 (1240.6 to 1893.2)     Anti-HBs, Month 21 95206.4 (72395.4 to 125204.9) 116458.1 (86865.7 to 156131.6)
No statistical analyses for this end point

Secondary: Antibody concentrations against Hepatitis B surface antigen (anti-HBs) Top of page

Secondary: Antibody titers against poliomyelitis (anti-polio) type 1, 2 and 3 Top of page
End point title	Antibody titers against poliomyelitis (anti-polio) type 1, 2 and 3 [24]
End point description	Anti-Polio 1, 2 and 3 antibody titers were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was an antibody titer ≥ 1:8.
End point type	Secondary
End point timeframe	At Day 0 and at Month 3
Notes [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values GSK257049 [6-12W] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 931 474 Units: Titer geometric mean (confidence interval 95%)     Anti-Polio 1, Day 0 47.4 (41.7 to 53.8) 43.3 (36.2 to 51.9)     Anti-Polio 1, Month 3 334.9 (295.2 to 379.8) 417.6 (351.4 to 496.2)     Anti-Polio 2, Day 0 38.6 (34.6 to 43.2) 40.3 (34.2 to 47.5)     Anti-Polio 2, Month 3 372.1 (334.5 to 414.0) 450.8 (393.9 to 516.0)     Anti-Polio 3, Day 0 9.4 (8.6 to 10.3) 9.1 (8.0 to 10.3)     Anti-Polio 3, Month 3 80.0 (71.0 to 90.1) 95.9 (82.0 to 112.2)
No statistical analyses for this end point

Secondary: Antibody titers against poliomyelitis (anti-polio) type 1, 2 and 3 Top of page

Secondary: Number of subjects with any and grade 3 solicited local symptoms. Top of page
End point title	Number of subjects with any and grade 3 solicited local symptoms.
End point description	Assessed solicited local symptoms included pain, redness and swelling. Any = the incidence of a particular symptom, regardless of intensity grade. Grade 3 pain = cried when limb was moved, spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
End point type	Secondary
End point timeframe	During the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 1479 1462 721 738 Units: Participants     Any Pain, Dose 1 247 435 61 215     Grade 3 Pain, Dose 1 0 10 0 7     Any Redness, Dose 1 66 176 26 89     Grade 3 Redness, Dose 1 2 3 0 3     Any Swelling, Dose 1 140 227 77 125     Grade 3 Swelling, Dose 1 6 27 0 29     Any Pain, Dose 2 179 383 41 178     Grade 3 Pain, Dose 2 3 5 0 3     Any Redness, Dose 2 26 124 18 90     Grade 3 Redness, Dose 2 3 3 0 1     Any Swelling, Dose 2 140 228 50 128     Grade 3 Swelling, Dose 2 15 29 0 17     Any Pain, Dose 3 108 345 22 153     Grade 3 Pain, Dose 3 0 8 0 2     Any Redness, Dose 3 42 113 13 63     Grade 3 Redness, Dose 3 2 1 0 1     Any Swelling, Dose 3 134 185 35 111     Grade 3 Swelling, Dose 3 9 9 0 12     Any Pain, Across doses 401 705 105 342     Grade 3 Pain, Across doses 3 23 0 12     Any Redness, Across doses 122 292 49 163     Grade 3 Redness, Across doses 6 7 0 5     Any Swelling, Across doses 303 427 119 248     Grade 3 Swelling, Across doses 25 59 0 53
No statistical analyses for this end point

Secondary: Number of subjects with any and grade 3 solicited local symptoms. Top of page

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms. Top of page
End point title	Number of subjects with any, grade 3 and related solicited general symptoms.
End point description	Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
End point type	Secondary
End point timeframe	During the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 1479 1462 721 738 Units: Participants     Any Drowsiness, Dose 1 91 164 27 65     Grade 3 Drowsiness, Dose 1 3 1 0 1     Related Drowsiness, Dose 1 33 88 8 26     Any Irritability, Dose 1 165 370 41 157     Grade 3 Irritability, Dose 1 0 10 0 3     Related Irritability, Dose 1 64 226 16 84     Any Loss of appetite, Dose 1 202 124 71 52     Grade 3 Loss of appetite, Dose 1 3 2 0 0     Related Loss of appetite, Dose 1 71 67 24 24     Any Fever, Dose 1 385 459 108 192     Grade 3 Fever, Dose 1 29 5 7 2     Related Fever, Dose 1 200 326 52 127     Any Drowsiness, Dose 2 99 135 37 55     Grade 3 Drowsiness, Dose 2 1 0 0 0     Related Drowsiness, Dose 2 61 74 26 15     Any Irritability, Dose 2 192 289 45 123     Grade 3 Irritability, Dose 2 2 7 0 0     Related Irritability, Dose 2 114 175 28 57     Any Loss of appetite, Dose 2 151 105 47 43     Grade 3 Loss of appetite, Dose 2 0 0 0 0     Related Loss of appetite, Dose 2 89 60 24 8     Any Fever, Dose 2 503 411 100 154     Grade 3 Fever, Dose 2 42 9 10 6     Related Fever, Dose 2 267 278 42 89     Any Drowsiness, Dose 3 97 124 29 44     Grade 3 Drowsiness, Dose 3 1 1 0 1     Related Drowsiness, Dose 3 52 49 16 19     Any Irritability, Dose 3 138 287 27 104     Grade 3 Irritability, Dose 3 1 3 0 2     Related Irritability, Dose 3 76 144 15 54     Any Loss of appetite, Dose 3 138 106 40 45     Grade 3 Loss of appetite, Dose 3 2 0 0 1     Related Loss of appetite, Dose 3 76 44 18 20     Any Fever, Dose 3 457 429 77 111     Grade 3 Fever, Dose 3 39 13 7 3     Related Fever, Dose 3 262 280 32 57     Any Drowsiness, Across doses 230 285 78 121     Grade 3 Drowsiness, Across doses 5 2 0 2     Related Drowsiness, Across doses 121 144 44 51     Any Irritability, Across doses 369 574 96 244     Grade 3 Irritability, Across doses 3 17 0 5     Related Irritability, Across doses 207 363 54 139     Any Loss of appetite, Across doses 398 243 132 104     Grade 3 Loss of appetite, Across doses 5 2 0 1     Related Loss of appetite, Across doses 206 128 61 41     Any Fever, Across doses 897 839 235 331     Grade 3 Fever, Across doses 105 26 24 11     Related Fever, Across doses 547 598 110 209
No statistical analyses for this end point

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms. Top of page

Secondary: Number of subjects with any and grade 3 solicited local symptoms Top of page
End point title	Number of subjects with any and grade 3 solicited local symptoms [25]
End point description	Assessed solicited local symptoms included pain, redness and swelling. Any = the incidence of a particular symptom, regardless of intensity grade. Grade 3 pain = cried when limb was moved, spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
End point type	Secondary
End point timeframe	During the 7-day (Days 0-6) post-booster vaccination period
Notes [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 633 621 641 639 608 625 Units: Participants     Any Pain 41 25 109 45 59 29     Grade 3 Pain 0 0 0 0 0 0     Any Redness 8 9 15 13 9 12     Grade 3 Redness 0 0 3 0 1 0     Any Swelling 30 43 42 35 45 28     Grade 3 Swelling 0 2 9 1 5 0
No statistical analyses for this end point

Secondary: Number of subjects with any and grade 3 solicited local symptoms Top of page

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms Top of page
End point title	Number of subjects with any, grade 3 and related solicited general symptoms [26]
End point description	Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
End point type	Secondary
End point timeframe	During the 7-day (Days 0-6) post-booster vaccination period
Notes [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 633 621 641 639 608 625 Units: Participants     Any Drowsiness 21 15 55 22 33 19     Grade 3 Drowsiness 0 0 1 0 0 0     Related Drowsiness 13 5 34 10 19 6     Any Irritability 18 23 63 25 46 23     Grade 3 Irritability 0 0 1 0 0 0     Related Irritability 8 6 40 12 27 10     Any Loss of appetite 21 18 66 27 45 27     Grade 3 Loss of appetite 0 0 1 0 0 0     Related Loss of appetite 13 6 39 14 26 8     Any Fever 45 58 233 70 152 52     Grade 3 Fever 5 10 34 6 9 7     Related Fever 16 18 151 29 80 15
No statistical analyses for this end point

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms Top of page

Secondary: Number of doses with seizures by diagnostic certainty level Top of page
End point title	Number of doses with seizures by diagnostic certainty level [27]
End point description	Diagnostic certainty levels included: Level 1- Witnessed sudden loss of consciousness and generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations; Level 2- History of unconsciousness and generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations; Level 3- History of unconsciousness and other generalized motor manifestations; Level 4- Reported generalized convulsive seizure with insufficient evidence to meet the case definition; Level 5- Not a case of generalized convulsive seizure.
End point type	Secondary
End point timeframe	During the 7-day (Days 0-6) post-booster vaccination period, at Month 20 + 7 Day (Days 0-6)
Notes [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2473 1827 2447 2472 1825 1837 Units: Doses     Level 1 0 0 1 1 1 0     Level 2 1 1 5 2 3 0     Level 3 0 0 0 0 0 0     Level 4 0 0 1 0 0 0     Level 5 0 0 1 1 0 0
No statistical analyses for this end point

Secondary: Number of doses with seizures by diagnostic certainty level Top of page

Secondary: Number of subjects reporting mucocutaneous changes (all levels) Top of page
End point title	Number of subjects reporting mucocutaneous changes (all levels) [28]
End point description	Levels of mucocutaneous changes reported were: cutaneous and mucosal change; cutaneous only change; mucosal only change; cutaneous change focused on the nappy/diaper area. Mucocutaneous changes results calculated based on the first 200 subjects in the 6-12 weeks age category in each study center were enrolled, and with available data (i.e. who received a booster dose).
End point type	Secondary
End point timeframe	During the 30-day (Days 0-29) post-booster vaccination
Notes [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values Menjugate Comparator [6-12W] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 614 605 617 Units: Participants 59 64 47
No statistical analyses for this end point

Secondary: Number of subjects reporting mucocutaneous changes (all levels) Top of page

Secondary: Number of subjects reporting any meningitis and encephalitis serious adverse events (SAEs) Top of page
End point title	Number of subjects reporting any meningitis and encephalitis serious adverse events (SAEs) [29]
End point description	Meningitis and encephalitis SAEs included: meningitis/encephalitis; meningitis/encephalitis viral; meningism; meningitis haemophilus; meningitis meningococcal; meningitis pneumococcal; meningitis tuberculous; encephalomyelitis.
End point type	Secondary
End point timeframe	At Month 0 until study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Notes [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2974 2179 2976 2972 2180 2178 Units: Participants 5 7 15 12 7 8
No statistical analyses for this end point

Secondary: Number of subjects reporting any meningitis and encephalitis serious adverse events (SAEs) Top of page

Secondary: Number of subjects reporting any meningitis and encephalitis SAEs Top of page
End point title	Number of subjects reporting any meningitis and encephalitis SAEs [30]
End point description	Meningitis and encephalitis SAEs included: meningitis/encephalitis; meningitis haemophilus; meningitis meningococcal; meningitis tuberculous; encephalomyelitis.
End point type	Secondary
End point timeframe	From Booster up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Notes [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2702 1976 2681 2719 1966 1996 Units: Participants 0 3 4 4 0 2
No statistical analyses for this end point

Secondary: Number of subjects reporting any meningitis and encephalitis SAEs Top of page

Secondary: Number of subjects reporting any potential immune-mediated disorders (pIMDs) Top of page
End point title	Number of subjects reporting any potential immune-mediated disorders (pIMDs) [31]
End point description	Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
End point type	Secondary
End point timeframe	From Month 0 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Notes [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2974 2179 2976 2972 2180 2178 Units: Participants 4 2 5 1 3 1
No statistical analyses for this end point

Secondary: Number of subjects reporting any potential immune-mediated disorders (pIMDs) Top of page

Secondary: Number of subjects with any unsolicited adverse events (AEs) Top of page
End point title	Number of subjects with any unsolicited adverse events (AEs)
End point description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited AEs were calculated based on the first 200 subjects enrolled in each study center.
End point type	Secondary
End point timeframe	Within the 30-day (Days 0-29) post-primary vaccination period
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 1479 1462 721 738 Units: Participants 1273 1161 626 600
No statistical analyses for this end point

Secondary: Number of subjects with any unsolicited adverse events (AEs) Top of page

Secondary: Number of subjects with unsolicited AEs related to or leading to vaccination withdrawal. Top of page
End point title	Number of subjects with unsolicited AEs related to or leading to vaccination withdrawal.
End point description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were calculated based on the first 200 subjects enrolled in each study center.
End point type	Secondary
End point timeframe	Within the 30-day (Days 0-29) post-primary vaccination period
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 3997 4358 2003 2179 Units: Participants 399 578 72 231
No statistical analyses for this end point

Secondary: Number of subjects with unsolicited AEs related to or leading to vaccination withdrawal. Top of page

Secondary: Number of subjects with any unsolicited AEs Top of page
End point title	Number of subjects with any unsolicited AEs [32]
End point description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited AEs were calculated based on the first 200 subjects enrolled in each study center.
End point type	Secondary
End point timeframe	Within the 30-day (days 0-29) post-booster vaccination period
Notes [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 633 621 641 639 608 625 Units: Participants 215 240 232 205 231 239
No statistical analyses for this end point

Secondary: Number of subjects with any unsolicited AEs Top of page

Secondary: Number of subjects with unsolicited AEs related to or leading to vaccination withdrawal Top of page
End point title	Number of subjects with unsolicited AEs related to or leading to vaccination withdrawal
End point description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were calculated based on the subgroup of the first 200 subjects enrolled in each study center, who were reported with HIV infected status ((HIV status either as per general medical history taken at screening or as identified by morbidity surveillance).
End point type	Secondary
End point timeframe	Within the 30-day (Days 0-29) post-primary and post-booster vaccination period in HIV-infected children
End point values GSK257049 Group GSK257049 -GSK257049 Group GSK257049 - Menjugate Group Comparator Group Number of subjects analysed 84 33 35 41 Units: Participants     Any AE(s), post-primary vaccination 13 0 0 3     Any AE(s), post-booster vaccination 0 2 0 0
No statistical analyses for this end point

Secondary: Number of subjects with unsolicited AEs related to or leading to vaccination withdrawal Top of page

Secondary: Number of subjects with unsolicited AEs related to or leading to vaccination withdrawal in the low-weight (LW) and very low-weight (VLW) category Top of page
End point title	Number of subjects with unsolicited AEs related to or leading to vaccination withdrawal in the low-weight (LW) and very low-weight (VLW) category
End point description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were calculated based on the subgroup of the first 200 subjects enrolled in each study center, who were reported with HIV infected status ((HIV status either as per general medical history taken at screening or as identified by morbidity surveillance). Low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was > -3 and ≤ -2. Very low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was ≤ -3.
End point type	Secondary
End point timeframe	Within the 30-day (Days 0-29) post-primary vaccination period in HIV-infected children
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 695 221 364 126 Units: Participants     Any AE(s), in LW 68 38 21 17     Any AE(s), in VLW 27 24 6 10
No statistical analyses for this end point

Secondary: Number of subjects with unsolicited AEs related to or leading to vaccination withdrawal in the low-weight (LW) and very low-weight (VLW) category Top of page

Secondary: Number of subjects with unsolicited AEs related to vaccination in the low-weight (LW) and very low-weight (VLW) category Top of page
End point title	Number of subjects with unsolicited AEs related to vaccination in the low-weight (LW) and very low-weight (VLW) category [33]
End point description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were calculated based on the subgroup of the first 200 subjects enrolled in each study center. Low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was > -3 and ≤ -2. Very low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was ≤ -3.
End point type	Secondary
End point timeframe	Within the 30-day (Days 0-29) post-booster vaccination period
Notes [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 293 195 273 297 230 208 Units: Participants     Any AE(s) in LW 0 0 4 1 2 0     Any AE(s) in VLW 1 1 5 0 2 0
No statistical analyses for this end point

Secondary: Number of subjects with unsolicited AEs related to vaccination in the low-weight (LW) and very low-weight (VLW) category Top of page

Secondary: Number of subjects with serious adverse events (SAEs) Top of page
End point title	Number of subjects with serious adverse events (SAEs)
End point description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
End point type	Secondary
End point timeframe	From Month 0 up to Month 14
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 5948 4358 2974 2179 Units: Participants 1040 782 634 419
No statistical analyses for this end point

Secondary: Number of subjects with serious adverse events (SAEs) Top of page

Secondary: Number of subjects with SAEs Top of page
End point title	Number of subjects with SAEs
End point description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
End point type	Secondary
End point timeframe	During the 30-day (Days 0-29) post-primary vaccination period
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 5948 4358 2974 2179 Units: Participants 312 192 181 96
No statistical analyses for this end point

Secondary: Number of subjects with SAEs Top of page

Secondary: Number of subjects with serious adverse events (SAEs). Top of page
End point title	Number of subjects with serious adverse events (SAEs).
End point description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
End point type	Secondary
End point timeframe	From Month 0 up to Month 20
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 5948 4358 2974 2179 Units: Participants 1108 959 676 503
No statistical analyses for this end point

Secondary: Number of subjects with serious adverse events (SAEs). Top of page

Secondary: Number of subjects with SAEs. Top of page
End point title	Number of subjects with SAEs. [34]
End point description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
End point type	Secondary
End point timeframe	From Booster (at Month 20) up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Notes [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2702 1976 2681 2719 1966 1996 Units: Participants 287 201 276 316 180 193
No statistical analyses for this end point

Secondary: Number of subjects with SAEs. Top of page

Secondary: Number of subjects with serious adverse events (SAEs) . Top of page
End point title	Number of subjects with serious adverse events (SAEs) . [35]
End point description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
End point type	Secondary
End point timeframe	From Month 0 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Notes [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2974 2179 2976 2972 2180 2178 Units: Participants 846 619 720 752 580 602
No statistical analyses for this end point

Secondary: Number of subjects with serious adverse events (SAEs) . Top of page

Secondary: Number of subjects with SAEs . Top of page
End point title	Number of subjects with SAEs . [36]
End point description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
End point type	Secondary
End point timeframe	Within the 30-day (Days 0-29) post-booster vaccination period
Notes [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 2473 1827 2447 2472 1825 1837 Units: Participants 27 20 34 22 19 19
No statistical analyses for this end point

Secondary: Number of subjects with SAEs . Top of page

Secondary: Number of subjects with serious adverse events [SAEs] Top of page
End point title	Number of subjects with serious adverse events [SAEs]
End point description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
End point type	Secondary
End point timeframe	From Month 0 up to Booster (Month 20), from Month 0 up to study end and from Month 20 up to study end
End point values GSK257049 -GSK257049 Group GSK257049 - Menjugate Group Comparator Group Number of subjects analysed 51 54 48 Units: Participants     Any SAE(s), Month 0 - Month 20 43 39 36     Any SAE(s), Month 0 - Study end 47 46 42     Any SAE(s), Month 20 - Study end 19 19 16
No statistical analyses for this end point

Secondary: Number of subjects with serious adverse events [SAEs] Top of page

Secondary: Number of low-weight (LW) subjects with serious adverse events (SAEs). Top of page
End point title	Number of low-weight (LW) subjects with serious adverse events (SAEs).
End point description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was > -3 and ≤ -2.
End point type	Secondary
End point timeframe	From Month 0 up to Month 20
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 695 221 364 126 Units: Participants 174 63 89 38
No statistical analyses for this end point

Secondary: Number of low-weight (LW) subjects with serious adverse events (SAEs). Top of page

Secondary: Number of low-weight (LW) subjects with serious adverse events (SAEs) Top of page
End point title	Number of low-weight (LW) subjects with serious adverse events (SAEs) [37]
End point description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was > -3 and ≤ -2.
End point type	Secondary
End point timeframe	From Booster (Month 20) up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Notes [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 297 195 277 304 232 211 Units: Participants 38 24 32 40 34 21
No statistical analyses for this end point

Secondary: Number of low-weight (LW) subjects with serious adverse events (SAEs) Top of page

Secondary: Number of very low-weight (VLW) subjects with serious adverse events (SAEs) Top of page
End point title	Number of very low-weight (VLW) subjects with serious adverse events (SAEs)
End point description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Very low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was ≤ -3.
End point type	Secondary
End point timeframe	From Month 0 up to Month 20
End point values GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Number of subjects analysed 207 147 97 67 Units: Participants 55 48 28 17
No statistical analyses for this end point

Secondary: Number of very low-weight (VLW) subjects with serious adverse events (SAEs) Top of page

Secondary: Number of very low-weight subjects with serious adverse events (SAEs) Top of page
End point title	Number of very low-weight subjects with serious adverse events (SAEs) [38]
End point description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Very low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was ≤ -3.
End point type	Secondary
End point timeframe	From Booster (Month 20) up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)]
Notes [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 60 68 48 50 48 47 Units: Participants 11 15 5 8 6 9
No statistical analyses for this end point

Secondary: Number of very low-weight subjects with serious adverse events (SAEs) Top of page

Secondary: Number of subjects with fatal outcomes, by gender Top of page
End point title	Number of subjects with fatal outcomes, by gender [39]
End point description	Mortality was presented as overall mortality (up to Month 20 and up to study end), mortality due to severe malaria as per secondary case definition(SCD), cerebral malaria as per secondary case definition (SCD), meningitis, fatal all-cause traumas and fatal malaria. SCD= Plasmodium falciparum malaria > 5000 parasites/mcL and 1 or more markers of severe malaria (prostration, respiratory distress, Blantyre score ≤ 2, seizures 2 or more, hypoglycemia < 2.2 mmol/L, acidosis BE ≤ -10.0 mmol/L,lactate ≥ 5.0 mmol/L, anemia < 5.0 g/dL.
End point type	Secondary
End point timeframe	From Month 0 up to study end (SE - median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Notes [39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.
End point values VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Number of subjects analysed 1503 1100 1509 1500 1116 1118 Units: Participants     Overall Mortality (M0-M20), Females 14 13 27 20 20 24     Overall Mortality (M0-SE), Females 17 16 35 32 27 29     Overall Mortality (M0-M20), Males 19 21 19 8 20 20     Overall Mortality (M0-SE), Males 29 26 26 19 24 26     Severe Malaria SCD, All, Females 100 75 75 107 57 49     Severe Malaria SCD, All, Males 134 79 87 115 78 80     Severe Malaria SCD, Fatal, Females 2 0 4 4 2 0     Severe Malaria SCD, Fatal, Males 2 2 3 4 2 2     Cerebral Malaria SCD, All, Females 7 7 16 14 1 5     Cerebral Malaria SCD, All, Males 9 3 10 14 9 7     Cerebral Malaria SCD, Fatal, Females 2 0 3 4 1 0     Cerebral Malaria SCD, Fatal, Males 0 0 2 1 1 1     Meningitis, All, Females 1 3 5 5 2 2     Meningitis, All, Males 2 3 6 5 3 5     Meningitis, Fatal, Females 0 1 2 3 0 0     Meningitis, Fatal, Males 1 2 2 0 1 1     Fatal All-Cause Traumas, Females 1 2 3 4 1 1     Fatal All-Cause Traumas, Males 3 0 4 1 1 2     Fatal Malaria, Females 4 3 9 8 5 4     Fatal Malaria, Males 8 3 4 9 3 8
No statistical analyses for this end point

Secondary: Number of subjects with fatal outcomes, by gender Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	Solicited local, general AEs: during 7-days (Days 0-6) post-vaccination periods; Unsolicited AEs: during 30-days (Days 0-29) post-vaccination periods; SAEs: from Day 0 up to study end (48 months for 5-17M subjects; 38 months for 6-12W subjects).
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	17.0
Reporting groups
Reporting group title	GSK257049 [5-17M] Group
Reporting group description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Reporting group title	Menjugate Comparator [6-12W] Group
Reporting group description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Reporting group title	VeroRab Comparator [5-17M] Group
Reporting group description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Reporting group title	GSK257049 [6-12W] Group
Reporting group description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Serious adverse events GSK257049 [5-17M] Group Menjugate Comparator [6-12W] Group VeroRab Comparator [5-17M] Group GSK257049 [6-12W] Group Total subjects affected by serious adverse events      subjects affected / exposed 1475 / 5948 (24.80%) 622 / 2179 (28.55%) 848 / 2974 (28.51%) 1186 / 4358 (27.21%)      number of deaths (all causes) 112 42 106 46      number of deaths resulting from adverse events Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute promyelocytic leukaemia      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Inflammatory pseudotumour      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Brain neoplasm      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Langerhans' cell histiocytosis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Vascular disorders Haematoma      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Shock      subjects affected / exposed 3 / 5948 (0.05%) 4 / 2179 (0.18%) 5 / 2974 (0.17%) 3 / 4358 (0.07%)      occurrences causally related to treatment / all 0 / 3 0 / 4 0 / 5 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hypovolaemic shock      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 General disorders and administration site conditions Death      subjects affected / exposed 4 / 5948 (0.07%) 3 / 2179 (0.14%) 0 / 2974 (0.00%) 3 / 4358 (0.07%)      occurrences causally related to treatment / all 0 / 4 0 / 3 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Drowning      subjects affected / exposed 5 / 5948 (0.08%) 1 / 2179 (0.05%) 3 / 2974 (0.10%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 5 0 / 1 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Generalised oedema      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hernia      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hypothermia      subjects affected / exposed 2 / 5948 (0.03%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 2 0 / 1 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Injection site reaction      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pyrexia      subjects affected / exposed 28 / 5948 (0.47%) 18 / 2179 (0.83%) 16 / 2974 (0.54%) 27 / 4358 (0.62%)      occurrences causally related to treatment / all 0 / 28 0 / 18 0 / 16 0 / 27      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Immune system disorders Allergy to arthropod sting      subjects affected / exposed 0 / 5948 (0.00%) 2 / 2179 (0.09%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 2 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Anaphylactic reaction      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Drug hypersensitivity      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hypersensitivity      subjects affected / exposed 3 / 5948 (0.05%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Immune reconstitution inflammatory syndrome      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Social circumstances Child abuse      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Sexual abuse      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Reproductive system and breast disorders Acquired phimosis      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory, thoracic and mediastinal disorders Apnoeic attack      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Asphyxia      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Aspiration      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Asthma      subjects affected / exposed 15 / 5948 (0.25%) 7 / 2179 (0.32%) 8 / 2974 (0.27%) 9 / 4358 (0.21%)      occurrences causally related to treatment / all 0 / 21 0 / 7 0 / 19 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Bronchial hyperreactivity      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Bronchospasm      subjects affected / exposed 2 / 5948 (0.03%) 5 / 2179 (0.23%) 3 / 2974 (0.10%) 8 / 4358 (0.18%)      occurrences causally related to treatment / all 0 / 2 0 / 7 0 / 3 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cough      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Interstitial lung disease      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Epistaxis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Obstructive airways disorder      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pleural effusion      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia aspiration      subjects affected / exposed 8 / 5948 (0.13%) 4 / 2179 (0.18%) 6 / 2974 (0.20%) 4 / 4358 (0.09%)      occurrences causally related to treatment / all 0 / 8 0 / 4 0 / 6 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pulmonary oedema      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonitis      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory acidosis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory arrest      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory disorder      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Psychiatric disorders Neurodevelopmental disorder      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Injury, poisoning and procedural complications Accidental exposure to product      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Accidental poisoning      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Animal bite      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Arthropod sting      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Bronchitis chemical      subjects affected / exposed 4 / 5948 (0.07%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 4 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Burns first degree      subjects affected / exposed 4 / 5948 (0.07%) 1 / 2179 (0.05%) 1 / 2974 (0.03%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 4 0 / 1 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Burns second degree      subjects affected / exposed 6 / 5948 (0.10%) 3 / 2179 (0.14%) 2 / 2974 (0.07%) 5 / 4358 (0.11%)      occurrences causally related to treatment / all 0 / 6 0 / 3 0 / 2 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Chemical injury      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Chemical poisoning      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 7 / 2974 (0.24%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 7 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Clavicle fracture      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Crush injury      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Disinfectant poisoning      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Dislocation of vertebra      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Exposure to toxic agent      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Eye contusion      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Eye injury      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Femur fracture      subjects affected / exposed 3 / 5948 (0.05%) 2 / 2179 (0.09%) 1 / 2974 (0.03%) 4 / 4358 (0.09%)      occurrences causally related to treatment / all 0 / 3 0 / 2 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Foreign body      subjects affected / exposed 5 / 5948 (0.08%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 5 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Foreign body aspiration      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Fractured skull depressed      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Greenstick fracture      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Head injury      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 4 / 4358 (0.09%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Herbal toxicity      subjects affected / exposed 5 / 5948 (0.08%) 3 / 2179 (0.14%) 2 / 2974 (0.07%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 5 0 / 3 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Human bite      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Humerus fracture      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Joint injury      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Laceration      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Limb injury      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Limb traumatic amputation      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Penis injury      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Petroleum distillate poisoning      subjects affected / exposed 4 / 5948 (0.07%) 1 / 2179 (0.05%) 4 / 2974 (0.13%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 1 0 / 4 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonitis chemical      subjects affected / exposed 5 / 5948 (0.08%) 0 / 2179 (0.00%) 4 / 2974 (0.13%) 4 / 4358 (0.09%)      occurrences causally related to treatment / all 0 / 5 0 / 0 0 / 4 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Poisoning      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pulmonary contusion      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Road traffic accident      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Sciatic nerve injury      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Skin injury      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Snake bite      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Soft tissue injury      subjects affected / exposed 2 / 5948 (0.03%) 3 / 2179 (0.14%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 2 0 / 3 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Thermal burn      subjects affected / exposed 25 / 5948 (0.42%) 11 / 2179 (0.50%) 15 / 2974 (0.50%) 24 / 4358 (0.55%)      occurrences causally related to treatment / all 0 / 26 0 / 11 0 / 15 0 / 24      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Tibia fracture      subjects affected / exposed 1 / 5948 (0.02%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Vaccination failure      subjects affected / exposed 0 / 5948 (0.00%) 2 / 2179 (0.09%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 0 0 / 2 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Wound      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Wrist fracture      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Congenital, familial and genetic disorders Atrial septal defect      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cerebral palsy      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Choledochal cyst      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Congenital megacolon      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cryptorchism      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Fallot's tetralogy      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Glucose-6-phosphate dehydrogenase deficiency      subjects affected / exposed 2 / 5948 (0.03%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hydrocele      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Phimosis      subjects affected / exposed 1 / 5948 (0.02%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Sickle cell anaemia      subjects affected / exposed 5 / 5948 (0.08%) 5 / 2179 (0.23%) 1 / 2974 (0.03%) 4 / 4358 (0.09%)      occurrences causally related to treatment / all 0 / 5 0 / 5 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Sickle cell anaemia with crisis      subjects affected / exposed 8 / 5948 (0.13%) 5 / 2179 (0.23%) 6 / 2974 (0.20%) 5 / 4358 (0.11%)      occurrences causally related to treatment / all 0 / 15 0 / 10 0 / 8 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Trisomy 21      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Urethral valves      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Ventricular septal defect      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac disorders Cardiac arrest      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac failure      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cardiomyopathy      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pericardial effusion      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Nervous system disorders Arachnoid cyst      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cerebellar ataxia      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cerebral atrophy      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Convulsion      subjects affected / exposed 102 / 5948 (1.71%) 32 / 2179 (1.47%) 58 / 2974 (1.95%) 78 / 4358 (1.79%)      occurrences causally related to treatment / all 0 / 122 0 / 45 0 / 64 0 / 98      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Depressed level of consciousness      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Encephalomalacia      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Encephalopathy      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Epilepsy      subjects affected / exposed 13 / 5948 (0.22%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 3 / 4358 (0.07%)      occurrences causally related to treatment / all 0 / 14 0 / 0 0 / 2 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Febrile convulsion      subjects affected / exposed 344 / 5948 (5.78%) 103 / 2179 (4.73%) 166 / 2974 (5.58%) 191 / 4358 (4.38%)      occurrences causally related to treatment / all 0 / 466 0 / 127 0 / 221 0 / 248      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Haemorrhage intracranial      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hemiparesis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hemiplegia      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hydrocephalus      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Loss of consciousness      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Meningism      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Metabolic encephalopathy      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Mental retardation      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Monoparesis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Paraparesis      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Myoclonus      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Uraemic encephalopathy      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Speech disorder developmental      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Blood and lymphatic system disorders Anaemia      subjects affected / exposed 277 / 5948 (4.66%) 116 / 2179 (5.32%) 198 / 2974 (6.66%) 198 / 4358 (4.54%)      occurrences causally related to treatment / all 0 / 329 0 / 138 0 / 246 0 / 258      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Disseminated intravascular coagulation      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Haemolysis      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Haemolytic anaemia      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hypochromic anaemia      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Intravascular haemolysis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Leukaemoid reaction      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Lymphadenitis      subjects affected / exposed 7 / 5948 (0.12%) 2 / 2179 (0.09%) 1 / 2974 (0.03%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 7 0 / 2 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Neutropenia      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pancytopenia      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Thrombocytopenia      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Ear and labyrinth disorders Deafness      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hearing impaired      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Eye disorders Periorbital oedema      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Gastrointestinal disorders Abdominal pain      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Aphthous stomatitis      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Colitis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Constipation      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Enteritis      subjects affected / exposed 28 / 5948 (0.47%) 18 / 2179 (0.83%) 15 / 2974 (0.50%) 17 / 4358 (0.39%)      occurrences causally related to treatment / all 0 / 28 0 / 18 0 / 15 0 / 17      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Food poisoning      subjects affected / exposed 1 / 5948 (0.02%) 1 / 2179 (0.05%) 2 / 2974 (0.07%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Gastritis      subjects affected / exposed 2 / 5948 (0.03%) 4 / 2179 (0.18%) 2 / 2974 (0.07%) 3 / 4358 (0.07%)      occurrences causally related to treatment / all 0 / 2 0 / 4 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Gastrointestinal haemorrhage      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Gastrointestinal motility disorder      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Gastrooesophageal reflux disease      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Haematemesis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Ileus paralytic      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Inguinal hernia      subjects affected / exposed 0 / 5948 (0.00%) 3 / 2179 (0.14%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 3 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Inguinal hernia, obstructive      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Intestinal obstruction      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Intestinal perforation      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Intussusception      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Mouth ulceration      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Rectal polyp      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Rectal prolapse      subjects affected / exposed 1 / 5948 (0.02%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Stomatitis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Stress ulcer      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Umbilical hernia      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Umbilical hernia, obstructive      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Upper gastrointestinal haemorrhage      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Vomiting      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hepatobiliary disorders Cholecystitis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hepatitis      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hepatitis acute      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hepatitis toxic      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Skin and subcutaneous tissue disorders Dermatitis      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Dermatitis allergic      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Dermatitis exfoliative      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Drug eruption      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Erythema multiforme      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Rash      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Rash maculo-papular      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Rash papular      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Stevens-johnson syndrome      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Skin lesion      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Urticaria      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Vitiligo      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Renal and urinary disorders Glomerulonephritis      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Glomerulonephritis acute      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Nephritis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hydronephrosis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Nephrotic syndrome      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Renal failure acute      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Renal tubular necrosis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Urinary retention      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Musculoskeletal and connective tissue disorders Arthritis      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Compartment syndrome      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Joint effusion      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Dactylitis      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Osteoarthritis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Myositis      subjects affected / exposed 3 / 5948 (0.05%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Torticollis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Rickets      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Infections and infestations Abscess      subjects affected / exposed 14 / 5948 (0.24%) 5 / 2179 (0.23%) 5 / 2974 (0.17%) 12 / 4358 (0.28%)      occurrences causally related to treatment / all 0 / 14 0 / 5 0 / 5 0 / 12      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Abscess jaw      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Abscess limb      subjects affected / exposed 1 / 5948 (0.02%) 1 / 2179 (0.05%) 3 / 2974 (0.10%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Abscess neck      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Acarodermatitis      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Aids dementia complex      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Amoebiasis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Arthritis bacterial      subjects affected / exposed 9 / 5948 (0.15%) 1 / 2179 (0.05%) 1 / 2974 (0.03%) 6 / 4358 (0.14%)      occurrences causally related to treatment / all 0 / 9 0 / 1 0 / 1 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Ascariasis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Atypical pneumonia      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Bacteraemia      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Bacterial infection      subjects affected / exposed 1 / 5948 (0.02%) 2 / 2179 (0.09%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 2 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Bone tuberculosis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Brain abscess      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Breast abscess      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Bronchiolitis      subjects affected / exposed 38 / 5948 (0.64%) 24 / 2179 (1.10%) 18 / 2974 (0.61%) 32 / 4358 (0.73%)      occurrences causally related to treatment / all 0 / 42 0 / 26 0 / 24 0 / 33      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Bronchitis      subjects affected / exposed 28 / 5948 (0.47%) 3 / 2179 (0.14%) 21 / 2974 (0.71%) 17 / 4358 (0.39%)      occurrences causally related to treatment / all 0 / 31 0 / 3 0 / 22 0 / 18      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Bronchopneumonia      subjects affected / exposed 68 / 5948 (1.14%) 34 / 2179 (1.56%) 40 / 2974 (1.34%) 54 / 4358 (1.24%)      occurrences causally related to treatment / all 0 / 76 0 / 36 0 / 42 0 / 60      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Bullous impetigo      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Burkholderia cepacia complex sepsis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Burn infection      subjects affected / exposed 3 / 5948 (0.05%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 1 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Candida infection      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cellulitis      subjects affected / exposed 15 / 5948 (0.25%) 6 / 2179 (0.28%) 6 / 2974 (0.20%) 10 / 4358 (0.23%)      occurrences causally related to treatment / all 0 / 15 0 / 6 0 / 6 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cellulitis of male external genital organ      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cellulitis orbital      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cellulitis pharyngeal      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Central nervous system viral infection      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cerebral malaria      subjects affected / exposed 8 / 5948 (0.13%) 2 / 2179 (0.09%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 8 0 / 2 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Cholera      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Conjunctivitis      subjects affected / exposed 6 / 5948 (0.10%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 6 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Conjunctivitis bacterial      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Croup infectious      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Dermatitis infected      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Disseminated tuberculosis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Dysentery      subjects affected / exposed 24 / 5948 (0.40%) 7 / 2179 (0.32%) 9 / 2974 (0.30%) 10 / 4358 (0.23%)      occurrences causally related to treatment / all 0 / 24 0 / 7 0 / 9 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Eczema infected      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Empyema      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Encephalitis      subjects affected / exposed 5 / 5948 (0.08%) 1 / 2179 (0.05%) 2 / 2974 (0.07%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 5 0 / 1 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Encephalitis viral      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Encephalomyelitis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Enterococcal sepsis      subjects affected / exposed 1 / 5948 (0.02%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Erysipelas      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Escherichia sepsis      subjects affected / exposed 0 / 5948 (0.00%) 2 / 2179 (0.09%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 0 0 / 2 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Escherichia urinary tract infection      subjects affected / exposed 1 / 5948 (0.02%) 2 / 2179 (0.09%) 2 / 2974 (0.07%) 3 / 4358 (0.07%)      occurrences causally related to treatment / all 0 / 1 0 / 2 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Exanthema subitum      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Febrile infection      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Furuncle      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Gastroenteritis      subjects affected / exposed 302 / 5948 (5.08%) 171 / 2179 (7.85%) 177 / 2974 (5.95%) 333 / 4358 (7.64%)      occurrences causally related to treatment / all 0 / 335 0 / 192 0 / 192 0 / 379      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Gastroenteritis escherichia coli      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Gastroenteritis salmonella      subjects affected / exposed 5 / 5948 (0.08%) 4 / 2179 (0.18%) 0 / 2974 (0.00%) 7 / 4358 (0.16%)      occurrences causally related to treatment / all 0 / 5 0 / 4 0 / 0 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Gastroenteritis shigella      subjects affected / exposed 1 / 5948 (0.02%) 1 / 2179 (0.05%) 1 / 2974 (0.03%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Gastroenteritis viral      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Gastrointestinal candidiasis      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Giardiasis      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 1 / 2974 (0.03%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Gingivitis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Groin abscess      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Haemophilus sepsis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Helminthic infection      subjects affected / exposed 10 / 5948 (0.17%) 1 / 2179 (0.05%) 6 / 2974 (0.20%) 3 / 4358 (0.07%)      occurrences causally related to treatment / all 0 / 12 0 / 1 0 / 6 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hepatitis a      subjects affected / exposed 4 / 5948 (0.07%) 1 / 2179 (0.05%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 4 0 / 1 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hepatitis b      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hepatitis infectious      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hiv associated nephropathy      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hiv infection      subjects affected / exposed 41 / 5948 (0.69%) 12 / 2179 (0.55%) 18 / 2974 (0.61%) 36 / 4358 (0.83%)      occurrences causally related to treatment / all 0 / 41 0 / 12 0 / 18 0 / 36      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hiv infection who clinical stage ii      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hiv infection who clinical stage iii      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hiv infection who clinical stage iv      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Impetigo      subjects affected / exposed 3 / 5948 (0.05%) 1 / 2179 (0.05%) 3 / 2974 (0.10%) 4 / 4358 (0.09%)      occurrences causally related to treatment / all 0 / 3 0 / 1 0 / 3 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Infected skin ulcer      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Infection      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Injection site abscess      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Injection site cellulitis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Klebsiella sepsis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Laryngitis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Listeria sepsis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Liver abscess      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Lobar pneumonia      subjects affected / exposed 11 / 5948 (0.18%) 7 / 2179 (0.32%) 7 / 2974 (0.24%) 17 / 4358 (0.39%)      occurrences causally related to treatment / all 0 / 11 0 / 8 0 / 8 0 / 18      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Lower respiratory tract infection      subjects affected / exposed 5 / 5948 (0.08%) 2 / 2179 (0.09%) 6 / 2974 (0.20%) 4 / 4358 (0.09%)      occurrences causally related to treatment / all 0 / 5 0 / 2 0 / 6 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Ludwig angina      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Lymph node abscess      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Lymph node tuberculosis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Lymphadenitis bacterial      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Malaria      subjects affected / exposed 639 / 5948 (10.74%) 236 / 2179 (10.83%) 423 / 2974 (14.22%) 392 / 4358 (8.99%)      occurrences causally related to treatment / all 0 / 850 0 / 303 0 / 533 0 / 525      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Mastoiditis      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Measles      subjects affected / exposed 9 / 5948 (0.15%) 8 / 2179 (0.37%) 5 / 2974 (0.17%) 24 / 4358 (0.55%)      occurrences causally related to treatment / all 0 / 9 0 / 8 0 / 5 0 / 24      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Meningitis      subjects affected / exposed 10 / 5948 (0.17%) 3 / 2179 (0.14%) 1 / 2974 (0.03%) 5 / 4358 (0.11%)      occurrences causally related to treatment / all 0 / 10 0 / 3 0 / 1 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Meningitis haemophilus      subjects affected / exposed 3 / 5948 (0.05%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 1 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Meningitis meningococcal      subjects affected / exposed 5 / 5948 (0.08%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 5 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Meningitis pneumococcal      subjects affected / exposed 1 / 5948 (0.02%) 2 / 2179 (0.09%) 0 / 2974 (0.00%) 3 / 4358 (0.07%)      occurrences causally related to treatment / all 0 / 1 0 / 2 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Meningitis salmonella      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 4 / 4358 (0.09%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Meningitis tuberculous      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Meningitis viral      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Moraxella infection      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Mumps      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Mycobacterium ulcerans infection      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Nasopharyngitis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Oral candidiasis      subjects affected / exposed 10 / 5948 (0.17%) 1 / 2179 (0.05%) 4 / 2974 (0.13%) 3 / 4358 (0.07%)      occurrences causally related to treatment / all 0 / 10 0 / 1 0 / 5 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Oropharyngeal candidiasis      subjects affected / exposed 2 / 5948 (0.03%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Osteomyelitis      subjects affected / exposed 5 / 5948 (0.08%) 2 / 2179 (0.09%) 3 / 2974 (0.10%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 5 0 / 2 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Otitis externa      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Otitis media      subjects affected / exposed 29 / 5948 (0.49%) 7 / 2179 (0.32%) 22 / 2974 (0.74%) 22 / 4358 (0.50%)      occurrences causally related to treatment / all 0 / 29 0 / 7 0 / 22 0 / 22      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Otitis media acute      subjects affected / exposed 4 / 5948 (0.07%) 1 / 2179 (0.05%) 2 / 2974 (0.07%) 3 / 4358 (0.07%)      occurrences causally related to treatment / all 0 / 4 0 / 1 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Otitis media chronic      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Parotitis      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Perineal abscess      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Periorbital cellulitis      subjects affected / exposed 1 / 5948 (0.02%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Peritonitis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pharyngitis      subjects affected / exposed 1 / 5948 (0.02%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Plasmodium ovale infection      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pneumococcal bacteraemia      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pneumococcal sepsis      subjects affected / exposed 9 / 5948 (0.15%) 3 / 2179 (0.14%) 3 / 2974 (0.10%) 9 / 4358 (0.21%)      occurrences causally related to treatment / all 0 / 9 0 / 3 0 / 3 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pneumocystis jirovecii pneumonia      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 5 / 4358 (0.11%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 1 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia      subjects affected / exposed 417 / 5948 (7.01%) 202 / 2179 (9.27%) 223 / 2974 (7.50%) 424 / 4358 (9.73%)      occurrences causally related to treatment / all 0 / 532 0 / 286 0 / 287 0 / 547      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia pneumococcal      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia streptococcal      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia viral      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Postoperative wound infection      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pseudomonal sepsis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pulmonary tuberculosis      subjects affected / exposed 8 / 5948 (0.13%) 2 / 2179 (0.09%) 4 / 2974 (0.13%) 12 / 4358 (0.28%)      occurrences causally related to treatment / all 0 / 9 0 / 2 0 / 4 0 / 12      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pyelonephritis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pyoderma      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 3 / 2974 (0.10%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Pyomyositis      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 3 / 2974 (0.10%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Rabies      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory tract infection      subjects affected / exposed 4 / 5948 (0.07%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 0 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Rubella      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Salmonella bacteraemia      subjects affected / exposed 0 / 5948 (0.00%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Salmonella sepsis      subjects affected / exposed 70 / 5948 (1.18%) 37 / 2179 (1.70%) 42 / 2974 (1.41%) 60 / 4358 (1.38%)      occurrences causally related to treatment / all 0 / 73 0 / 40 0 / 42 0 / 63      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Salmonellosis      subjects affected / exposed 4 / 5948 (0.07%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 4 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Schistosomiasis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Sepsis      subjects affected / exposed 60 / 5948 (1.01%) 13 / 2179 (0.60%) 43 / 2974 (1.45%) 38 / 4358 (0.87%)      occurrences causally related to treatment / all 0 / 61 0 / 15 0 / 46 0 / 38      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Septic shock      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Shigella infection      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Skin bacterial infection      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Skin infection      subjects affected / exposed 3 / 5948 (0.05%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Staphylococcal sepsis      subjects affected / exposed 9 / 5948 (0.15%) 2 / 2179 (0.09%) 1 / 2974 (0.03%) 10 / 4358 (0.23%)      occurrences causally related to treatment / all 0 / 10 0 / 2 0 / 1 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Staphylococcal skin infection      subjects affected / exposed 3 / 5948 (0.05%) 1 / 2179 (0.05%) 2 / 2974 (0.07%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 1 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Streptococcal infection      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Streptococcal sepsis      subjects affected / exposed 2 / 5948 (0.03%) 2 / 2179 (0.09%) 2 / 2974 (0.07%) 2 / 4358 (0.05%)      occurrences causally related to treatment / all 0 / 2 0 / 2 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Subcutaneous abscess      subjects affected / exposed 9 / 5948 (0.15%) 3 / 2179 (0.14%) 2 / 2974 (0.07%) 7 / 4358 (0.16%)      occurrences causally related to treatment / all 0 / 9 0 / 3 0 / 2 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Superinfection      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Taeniasis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Tinea capitis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Tonsillitis      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 3 / 2974 (0.10%) 3 / 4358 (0.07%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 3 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Toxic shock syndrome      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Tracheobronchitis      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Trichiniasis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Tuberculosis      subjects affected / exposed 9 / 5948 (0.15%) 3 / 2179 (0.14%) 6 / 2974 (0.20%) 6 / 4358 (0.14%)      occurrences causally related to treatment / all 0 / 9 0 / 3 0 / 6 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Typhoid fever      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 3 / 2974 (0.10%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 0 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Upper respiratory tract infection      subjects affected / exposed 68 / 5948 (1.14%) 24 / 2179 (1.10%) 43 / 2974 (1.45%) 50 / 4358 (1.15%)      occurrences causally related to treatment / all 0 / 74 0 / 24 0 / 45 0 / 52      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Urinary tract infection      subjects affected / exposed 45 / 5948 (0.76%) 22 / 2179 (1.01%) 28 / 2974 (0.94%) 26 / 4358 (0.60%)      occurrences causally related to treatment / all 0 / 47 0 / 23 0 / 29 0 / 28      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Urinary tract infection bacterial      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Urinary tract infection pseudomonal      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Urosepsis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Vaginal infection      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Varicella      subjects affected / exposed 1 / 5948 (0.02%) 1 / 2179 (0.05%) 1 / 2974 (0.03%) 3 / 4358 (0.07%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Viral infection      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Wound infection      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 2 / 2974 (0.07%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Wound sepsis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Metabolism and nutrition disorders Dehydration      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Failure to thrive      subjects affected / exposed 1 / 5948 (0.02%) 1 / 2179 (0.05%) 2 / 2974 (0.07%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hyperkalaemia      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hypoglycaemia      subjects affected / exposed 20 / 5948 (0.34%) 3 / 2179 (0.14%) 18 / 2974 (0.61%) 6 / 4358 (0.14%)      occurrences causally related to treatment / all 0 / 21 0 / 3 0 / 20 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hypokalaemia      subjects affected / exposed 1 / 5948 (0.02%) 1 / 2179 (0.05%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Hypoproteinaemia      subjects affected / exposed 2 / 5948 (0.03%) 0 / 2179 (0.00%) 1 / 2974 (0.03%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Kwashiorkor      subjects affected / exposed 15 / 5948 (0.25%) 4 / 2179 (0.18%) 17 / 2974 (0.57%) 16 / 4358 (0.37%)      occurrences causally related to treatment / all 0 / 18 0 / 4 0 / 17 0 / 17      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Malnutrition      subjects affected / exposed 54 / 5948 (0.91%) 19 / 2179 (0.87%) 21 / 2974 (0.71%) 50 / 4358 (1.15%)      occurrences causally related to treatment / all 0 / 58 0 / 21 0 / 25 0 / 58      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Marasmus      subjects affected / exposed 14 / 5948 (0.24%) 7 / 2179 (0.32%) 4 / 2974 (0.13%) 11 / 4358 (0.25%)      occurrences causally related to treatment / all 0 / 14 0 / 8 0 / 4 0 / 11      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Metabolic acidosis      subjects affected / exposed 0 / 5948 (0.00%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 1 / 4358 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 Underweight      subjects affected / exposed 1 / 5948 (0.02%) 0 / 2179 (0.00%) 0 / 2974 (0.00%) 0 / 4358 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0
Frequency threshold for reporting non-serious adverse events: 5%
Non-serious adverse events GSK257049 [5-17M] Group Menjugate Comparator [6-12W] Group VeroRab Comparator [5-17M] Group GSK257049 [6-12W] Group Total subjects affected by non serious adverse events      subjects affected / exposed 1410 / 5948 (23.71%) 691 / 2179 (31.71%) 664 / 2974 (22.33%) 1360 / 4358 (31.21%) Nervous system disorders Somnolence      subjects affected / exposed [1] 272 / 1479 (18.39%) 131 / 738 (17.75%) 87 / 721 (12.07%) 302 / 1462 (20.66%)      occurrences all number 364 179 115 475 General disorders and administration site conditions Pain      subjects affected / exposed [2] 493 / 1479 (33.33%) 348 / 738 (47.15%) 132 / 721 (18.31%) 729 / 1462 (49.86%)      occurrences all number 688 571 165 1251 Pyrexia      subjects affected / exposed [3] 1028 / 1479 (69.51%) 408 / 738 (55.28%) 306 / 721 (42.44%) 966 / 1462 (66.07%)      occurrences all number 1971 660 416 1852 Swelling      subjects affected / exposed [4] 352 / 1479 (23.80%) 272 / 738 (36.86%) 138 / 721 (19.14%) 456 / 1462 (31.19%)      occurrences all number 491 407 192 713 Gastrointestinal disorders Diarrhoea      subjects affected / exposed [5] 196 / 1479 (13.25%) 0 / 738 (0.00%) 92 / 721 (12.76%) 0 / 1462 (0.00%)      occurrences all number 226 0 107 0 Enteritis      subjects affected / exposed [6] 136 / 1479 (9.20%) 80 / 738 (10.84%) 65 / 721 (9.02%) 149 / 1462 (10.19%)      occurrences all number 148 97 74 195 Respiratory, thoracic and mediastinal disorders Cough      subjects affected / exposed [7] 119 / 1479 (8.05%) 0 / 738 (0.00%) 47 / 721 (6.52%) 0 / 1462 (0.00%)      occurrences all number 126 0 54 0 Skin and subcutaneous tissue disorders Erythema      subjects affected / exposed [8] 147 / 1479 (9.94%) 172 / 738 (23.31%) 57 / 721 (7.91%) 307 / 1462 (21.00%)      occurrences all number 162 254 66 436 Psychiatric disorders Irritability      subjects affected / exposed [9] 412 / 1479 (27.86%) 255 / 738 (34.55%) 106 / 721 (14.70%) 589 / 1462 (40.29%)      occurrences all number 583 411 131 1017 Infections and infestations Bronchitis      subjects affected / exposed [10] 83 / 1479 (5.61%) 33 / 738 (4.47%) 37 / 721 (5.13%) 69 / 1462 (4.72%)      occurrences all number 92 36 41 80 Conjunctivitis      subjects affected / exposed [11] 126 / 1479 (8.52%) 81 / 738 (10.98%) 74 / 721 (10.26%) 139 / 1462 (9.51%)      occurrences all number 135 87 77 147 Gastroenteritis      subjects affected / exposed [12] 368 / 1479 (24.88%) 150 / 738 (20.33%) 159 / 721 (22.05%) 257 / 1462 (17.58%)      occurrences all number 435 207 188 339 Malaria      subjects affected / exposed [13] 305 / 1479 (20.62%) 108 / 738 (14.63%) 207 / 721 (28.71%) 199 / 1462 (13.61%)      occurrences all number 422 141 289 249 Otitis media      subjects affected / exposed [14] 0 / 1479 (0.00%) 41 / 738 (5.56%) 0 / 721 (0.00%) 73 / 1462 (4.99%)      occurrences all number 0 42 0 82 Pneumonia      subjects affected / exposed [15] 175 / 1479 (11.83%) 33 / 738 (4.47%) 72 / 721 (9.99%) 87 / 1462 (5.95%)      occurrences all number 200 36 84 94 Rhinitis      subjects affected / exposed [16] 123 / 1479 (8.32%) 94 / 738 (12.74%) 52 / 721 (7.21%) 166 / 1462 (11.35%)      occurrences all number 139 109 59 183 Upper respiratory tract infection      subjects affected / exposed [17] 683 / 1479 (46.18%) 344 / 738 (46.61%) 343 / 721 (47.57%) 655 / 1462 (44.80%)      occurrences all number 1006 503 493 1014 Viral upper respiratory tract infection      subjects affected / exposed [18] 111 / 1479 (7.51%) 49 / 738 (6.64%) 60 / 721 (8.32%) 90 / 1462 (6.16%)      occurrences all number 126 55 69 111 Metabolism and nutrition disorders Decreased appetite      subjects affected / exposed [19] 444 / 1479 (30.02%) 114 / 738 (15.45%) 151 / 721 (20.94%) 281 / 1462 (19.22%)      occurrences all number 609 158 190 412
Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in. [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Solicited general events were only reported for subjects that has a symptom sheet filled-in.

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Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
Due to limitations in terms of record format and available reports, placeholder values were presented for the analysis sets' baseline characteristics.

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