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    Clinical Trial Results:
    Phase III randomized, open, controlled study to evaluate the immune response to the hepatitis B antigen of the RTS,S/AS01E candidate vaccine, when administered as primary vaccination integrated into an EPI regimen to infants living in sub-Saharan Africa.

    Summary
    EudraCT number
    		 2011-001508-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    09 Feb 2017

    Results information
    Results version number
    		 v1
    This version publication date
    17 Aug 2017
    First version publication date
    17 Aug 2017
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    113681
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01345240
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, 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
    Interim
    Date of interim/final analysis
    09 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate in terms of antibody (ab) response to the HBs antigen, the non-inferiority (noninf) of RTS,S/AS01E (RTSS) to a primary vaccination regimen of a licensed hepatitis B vaccine (Engerix-B) integrated into an expanded program on immunization (EPI) regimen.
    Protection of trial subjects
    The vaccinees were observed closely for at least 60 minutes following the administration of all vaccines used in the study, with appropriate medical treatment readily available in case of an anaphylactic reaction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 51 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Burkina Faso: 508
    Country: Number of subjects enrolled
    Ghana: 197
    Worldwide total number of subjects
    705
    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)
    705
    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

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was conducted in 4 phases, a Primary Vaccination Phase (up to Month (M) 3), a Safety Follow-Up Phase (M3-8), a First Immunogenicity Follow-Up (FU) Phase (M8-26), and a Second Immunogenicity FU Phase (M26 to study end at M51).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RTS,S Regimen A Group
    Arm description
    		 This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Candidate Plasmodium falciparum malaria vaccine
    Investigational medicinal product code
    RTS,S/AS02D
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh

    Investigational medicinal product name
    Engerix-B Junior
    Investigational medicinal product code
    HBV Paediatric 10
    Other name
    Engerix-B
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh.

    Investigational medicinal product name
    Infanrix-Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the deltoid.

    Investigational medicinal product name
    Polio Sabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3-dose orally

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2-dose orally

    Investigational medicinal product name
    Measles and yellow fever vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1-dose intramuscular injection in the deltoid

    Arm title
    		 RTS,S Regimen B Group
    Arm description
    		 This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Candidate Plasmodium falciparum malaria vaccine
    Investigational medicinal product code
    RTS,S/AS02D
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh

    Investigational medicinal product name
    Engerix-B Junior
    Investigational medicinal product code
    HBV Paediatric 10
    Other name
    Engerix-B
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh.

    Investigational medicinal product name
    Infanrix-Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the deltoid.

    Investigational medicinal product name
    Polio Sabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3-dose orally

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2-dose orally

    Investigational medicinal product name
    Measles and yellow fever vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1-dose intramuscular injection in the deltoid

    Arm title
    		 RTS,S Regimen C Group
    Arm description
    		 This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Candidate Plasmodium falciparum malaria vaccine
    Investigational medicinal product code
    RTS,S/AS02D
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh

    Investigational medicinal product name
    Engerix-B Junior
    Investigational medicinal product code
    HBV Paediatric 10
    Other name
    Engerix-B
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh.

    Investigational medicinal product name
    Infanrix-Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the deltoid.

    Investigational medicinal product name
    Polio Sabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3-dose orally

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2-dose orally

    Investigational medicinal product name
    Measles and yellow fever vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1-dose intramuscular injection in the deltoid

    Arm title
    		 Engerix B Regimen A Group
    Arm description
    		 Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Engerix-B Junior
    Investigational medicinal product code
    HBV Paediatric 10
    Other name
    Engerix-B
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh.

    Investigational medicinal product name
    Infanrix-Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the deltoid.

    Investigational medicinal product name
    Polio Sabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3-dose orally

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2-dose orally

    Investigational medicinal product name
    Measles and yellow fever vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1-dose intramuscular injection in the deltoid

    Arm title
    		 Engerix B Regimen B Group
    Arm description
    		 Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Engerix-B Junior
    Investigational medicinal product code
    HBV Paediatric 10
    Other name
    Engerix-B
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh.

    Investigational medicinal product name
    Infanrix-Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the deltoid.

    Investigational medicinal product name
    Polio Sabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3-dose orally

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2-dose orally

    Investigational medicinal product name
    Measles and yellow fever vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1-dose intramuscular injection in the deltoid

    Number of subjects in period 1
    		RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
    Started
    142
    142
    141
    141
    139
    Completed
    140
    128
    131
    131
    132
    Not completed
    2
    14
    10
    10
    7
         Lost to follow-up
    1
    12
    8
    8
    6
         Serious Adverse Event
    1
    2
    2
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RTS,S Regimen A Group
    Reporting group description
    		 This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group title
    RTS,S Regimen B Group
    Reporting group description
    		 This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group title
    RTS,S Regimen C Group
    Reporting group description
    		 This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group title
    Engerix B Regimen A Group
    Reporting group description
    		 Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group title
    Engerix B Regimen B Group
    Reporting group description
    		 Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group values
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group Total
    Number of subjects
    		 142 142 141 141 139
    Age categorical
    Units: Subjects
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 8.4 ± 0.83 8.3 ± 0.62 8.3 ± 0.69 8.3 ± 0.74 8.3 ± 0.74 -
    Gender categorical
    Units: Subjects
        Female
    		 59 69 67 81 63 339
        Male
    		 83 73 74 60 76 366
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage/African American
    		 142 142 141 141 139 705

    End points

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    End points reporting groups
    Reporting group title
    RTS,S Regimen A Group
    Reporting group description
    		 This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group title
    RTS,S Regimen B Group
    Reporting group description
    		 This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group title
    RTS,S Regimen C Group
    Reporting group description
    		 This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group title
    Engerix B Regimen A Group
    Reporting group description
    		 Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group title
    Engerix B Regimen B Group
    Reporting group description
    		 Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Subject analysis set title
    RTS,S Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Subject analysis set title
    Engerix B Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups were administered Engerix B™ as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™ and of vaccines against yellow fever and against measles. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Subject analysis set title
    RTS,S Lot 1 Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Subject analysis set title
    RTS,S Lot 2 Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Subject analysis set title
    RTS,S Lot 3 Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Primary: Anti-Hepatitis B (HBs) antibody concentrations

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    End point title
    		 Anti-Hepatitis B (HBs) antibody concentrations [1]
    End point description
    Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix-B™).
    End point type
    Primary
    End point timeframe
    At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RTS,S Group Engerix B Group
    Number of subjects analysed
    397
    253
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    6412.7 (5732.9 to 7173)
    377.4 (310.6 to 458.7)
    No statistical analyses for this end point

    Primary: Anti-Hepatitis B (HBs) antibody concentrations.

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    End point title
    		 Anti-Hepatitis B (HBs) antibody concentrations. [2]
    End point description
    Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by RTS,S or Engerix-B™ vaccination regimen received.
    End point type
    Primary
    End point timeframe
    At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
    Number of subjects analysed
    140
    123
    134
    135
    118
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    5467.6 (4493.8 to 6652.5)
    6989.9 (5747.5 to 8501)
    6998.7 (5779.1 to 8475.7)
    334.4 (253.4 to 441.4)
    433.4 (329.5 to 570.1)
    No statistical analyses for this end point

    Secondary: Anti-Hepatitis B (HBs) antibody concentrations

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    End point title
    		 Anti-Hepatitis B (HBs) antibody concentrations
    End point description
    Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for the study groups receiving the RTS,S vaccine, pooled by vaccine lot, that is, for the RTS,S Lot 1, RTS,S Lot 2, and RTS,S Lot 3 groups, as defined below.
    End point type
    Secondary
    End point timeframe
    At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™
    End point values
    		 RTS,S Lot 1 Group RTS,S Lot 2 Group RTS,S Lot 3 Group
    Number of subjects analysed
    132
    134
    131
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    6214.3 (5115.6 to 7548.9)
    6826.1 (5569.4 to 8366.3)
    6209.2 (5144.2 to 7494.8)
    No statistical analyses for this end point

    Secondary: Anti-Hepatitis B (HBs) antibody concentrations.

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    End point title
    		 Anti-Hepatitis B (HBs) antibody concentrations. [3]
    End point description
    Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL.
    End point type
    Secondary
    End point timeframe
    At Months 14 and 26, aka at 12 and 24 months post Dose 3 of RTS,S vaccine or Engerix-B™
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Engerix B Regimen A Group Engerix B Regimen B Group RTS,S Lot 1 Group RTS,S Lot 2 Group RTS,S Lot 3 Group
    Number of subjects analysed
    127
    114
    133
    118
    129
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs – At Month 14
    119.5 (91 to 157)
    137.5 (103.3 to 183.2)
    1530.1 (1259.4 to 1859.1)
    2430.9 (1975.7 to 2991)
    2189.1 (1840.3 to 2603.9)
        Anti-HBs – At Month 26
    68.8 (50.7 to 93.3)
    71 (51.6 to 97.8)
    1092.6 (867.4 to 1376.3)
    1896 (1487.2 to 2417.3)
    1849.8 (1478.9 to 2313.6)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies to the Hepatitis B RF1 surface antigen (anti-HBs RF1).

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    End point title
    		 Concentrations of antibodies to the Hepatitis B RF1 surface antigen (anti-HBs RF1).
    End point description
    Anti-HBs RF1 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™
    End point values
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
    Number of subjects analysed
    141
    123
    135
    135
    117
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        EL.U/mL
    268.7 (226.8 to 318.3)
    327.1 (272.2 to 393.1)
    335.5 (283.2 to 397.5)
    25.5 (22.8 to 28.7)
    28.7 (24.6 to 33.4)
    No statistical analyses for this end point

    Secondary: Anti-circumsporozoite protein (anti-CS) antibody concentrations

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    End point title
    		 Anti-circumsporozoite protein (anti-CS) antibody concentrations
    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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. The table shows results with study groups pooled by vaccination regimen received.
    End point type
    Secondary
    End point timeframe
    At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™
    End point values
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
    Number of subjects analysed
    141
    123
    136
    135
    118
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        EL.U/mL
    142.2 (116.4 to 173.7)
    188.5 (156.5 to 227)
    205.5 (167.3 to 252.5)
    99999 (99999 to 99999)
    0.3 (0.3 to 0.4)
    No statistical analyses for this end point

    Secondary: Anti-circumsporozoite protein (anti-CS) antibody concentrations .

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    End point title
    		 Anti-circumsporozoite protein (anti-CS) antibody concentrations . [4]
    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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    At Month 14, aka at 12 months post Dose 3 of RTS,S vaccine or Engerix-B™.
    Notes
    [4] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Engerix B Regimen A Group Engerix B Regimen B Group RTS,S Lot 1 Group RTS,S Lot 2 Group RTS,S Lot 3 Group
    Number of subjects analysed
    85
    76
    91
    82
    96
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        EL.U/mL
    0.3 (0.3 to 0.3)
    0.3 (0.3 to 0.4)
    5.7 (4.2 to 7.7)
    6.8 (5 to 9.4)
    7.5 (5.3 to 10.6)
    No statistical analyses for this end point

    Secondary: Pneumococcal antibody concentrations against Synflorix™ pneumococcal vaccine serotypes.

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    End point title
    		 Pneumococcal antibody concentrations against Synflorix™ pneumococcal vaccine serotypes. [5]
    End point description
    Antibody concentrations were measured by GSK assay, and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 µg/mL. This corresponds to a cut-off value of 0.35μg/mL by enzyme-linked immunosorbent assay (ELISA). This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Synflorix™. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.
    End point type
    Secondary
    End point timeframe
    At Month 3, aka at one month post Dose 3 of Synflorix™
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RTS,S Regimen A Group Engerix B Regimen A Group
    Number of subjects analysed
    141
    135
    Units: µg/mL
    geometric mean (confidence interval 95%)
        ANTI-1
    3.1 (2.8 to 3.6)
    3.6 (3.1 to 4.2)
        ANTI-4
    3.5 (3 to 4)
    4.2 (3.5 to 4.9)
        ANTI-5
    5.1 (4.5 to 5.8)
    6.5 (5.6 to 7.4)
        ANTI-6B
    1.1 (0.8 to 1.3)
    1.2 (1 to 1.6)
        ANTI-7F
    4.4 (3.9 to 4.9)
    4.9 (4.3 to 5.7)
        ANTI-9V
    2.8 (2.4 to 3.3)
    3.7 (3.3 to 4.2)
        ANTI-14
    5.8 (5 to 6.7)
    5.7 (4.7 to 7)
        ANTI-18C
    3.4 (2.8 to 4.1)
    6.2 (5.1 to 7.5)
        ANTI-19F
    4.2 (3.4 to 5.2)
    5.1 (4.1 to 6.4)
        ANTI-23F
    1.3 (1.1 to 1.6)
    1.5 (1.1 to 1.9)
    No statistical analyses for this end point

    Secondary: Pneumococcal antibody concentrations against Synflorix™ pneumococcal vaccine serotypes.

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    End point title
    		 Pneumococcal antibody concentrations against Synflorix™ pneumococcal vaccine serotypes. [6]
    End point description
    Antibody concentrations were measured by GSK assay, and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 μg/mL. This corresponds to a cut-off value of 0.35μg/mL by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Secondary
    End point timeframe
    At Month 17, aka one month post the Month 16 booster dose of Synflorix™
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RTS,S Regimen A Group Engerix B Regimen A Group
    Number of subjects analysed
    133
    126
    Units: μg/mL
    geometric mean (confidence interval 95%)
        ANTI-1
    4.5 (3.8 to 5.4)
    5.4 (4.5 to 6.4)
        ANTI-4
    6.1 (5.1 to 7.2)
    6.8 (5.7 to 8)
        ANTI-5
    6.5 (5.5 to 7.8)
    7.6 (6.4 to 9.1)
        ANTI-6B
    4.7 (4 to 5.5)
    4.1 (3.5 to 4.9)
        ANTI-7F
    7.1 (6.2 to 8.2)
    7.2 (6.3 to 8.2)
        ANTI-9V
    6 (5.1 to 7.1)
    5.7 (4.9 to 6.6)
        ANTI-14
    9 (7.6 to 10.7)
    9 (7.4 to 10.8)
        ANTI-18C
    13.7 (11.5 to 16.3)
    14.5 (12.3 to 17.2)
        ANTI-19F
    6 (4.9 to 7.4)
    7.2 (5.8 to 8.8)
        ANTI-23F
    4.1 (3.4 to 5.1)
    3.9 (3.2 to 4.8)
    No statistical analyses for this end point

    Secondary: Titers for opsonophagocytic activity against Synflorix™ pneumococcal vaccine serotypes.

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    End point title
    		 Titers for opsonophagocytic activity against Synflorix™ pneumococcal vaccine serotypes. [7]
    End point description
    The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8. This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Synflorix™. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.
    End point type
    Secondary
    End point timeframe
    At Month 3, aka at one month (1M) post Dose 3 of Synflorix™
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RTS,S Regimen A Group Engerix B Regimen A Group
    Number of subjects analysed
    133
    124
    Units: Titer
    geometric mean (confidence interval 95%)
        ANTI-1
    48.9 (34.6 to 68.9)
    65 (45 to 93.7)
        ANTI-4
    768.3 (617.6 to 955.8)
    810.9 (676.5 to 972)
        ANTI-5
    77.6 (61.9 to 97.3)
    93.8 (73.6 to 119.6)
        ANTI-6B
    444.4 (295 to 669.5)
    389.3 (250.1 to 606.1)
        ANTI-7F
    3774 (3232.7 to 4405.8)
    3947.4 (3338.3 to 4667.7)
        ANTI-9V
    1257.7 (977.3 to 1618.7)
    1469.3 (1180.4 to 1828.8)
        ANTI-14
    1426.3 (1136 to 1790.9)
    1269 (965.1 to 1668.6)
        ANTI-18C
    192.6 (139.2 to 266.4)
    249.7 (185 to 337)
        ANTI-19F
    159.3 (109.9 to 231)
    228.8 (160.4 to 326.3)
        ANTI-23F
    760.9 (476.3 to 1215.5)
    735.6 (456.3 to 1185.9)
    No statistical analyses for this end point

    Secondary: Titers for opsonophagocytic activity against Synflorix™ pneumococcal vaccine serotypes.

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    End point title
    		 Titers for opsonophagocytic activity against Synflorix™ pneumococcal vaccine serotypes. [8]
    End point description
    The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8.
    End point type
    Secondary
    End point timeframe
    At Month 17, aka one month post the Month 16 booster dose of Synflorix™
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RTS,S Regimen A Group Engerix B Regimen A Group
    Number of subjects analysed
    130
    121
    Units: Titer
    geometric mean (confidence interval 95%)
        Opsono-1
    649.9 (464.7 to 908.9)
    840.1 (603.4 to 1169.7)
        Opsono-4
    2347.1 (1847.4 to 2982)
    2527.8 (2064.1 to 3095.7)
        Opsono-5
    324.2 (244.1 to 430.5)
    392.8 (291.3 to 529.6)
        Opsono-6B
    955.3 (761.4 to 1198.6)
    828.2 (652.7 to 1050.9)
        Opsono-7F
    9167.3 (7979.2 to 10532.3)
    7794.6 (6577.6 to 9236.8)
        Opsono-9V
    3035.3 (2523.3 to 3651.3)
    3164.6 (2669.8 to 3751.1)
        Opsono-14
    1975.7 (1565.8 to 2493)
    1865 (1463.9 to 2375.9)
        Opsono-18C
    1694.1 (1188.6 to 2414.7)
    1548.7 (1096.3 to 2188)
        Opsono-19F
    344.5 (223 to 532.3)
    469.7 (320 to 689.4)
        Opsono-23F
    3199.8 (2543.7 to 4025.1)
    3198.1 (2526.5 to 4048.4)
    No statistical analyses for this end point

    Secondary: Anti-protein D (PD) antibody concentrations

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    End point title
    		 Anti-protein D (PD) antibody concentrations [9]
    End point description
    Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Synflorix™. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.
    End point type
    Secondary
    End point timeframe
    At Month 3, aka at one month post Dose 3 of Synflorix™
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RTS,S Regimen A Group Engerix B Regimen A Group
    Number of subjects analysed
    141
    134
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        EL.U/mL
    2435.3 (2204.3 to 2690.6)
    2956.7 (2647.5 to 3302.1)
    No statistical analyses for this end point

    Secondary: Anti-protein D (PD) antibody concentrations

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    End point title
    		 Anti-protein D (PD) antibody concentrations [10]
    End point description
    Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    At Month 17, aka one month post the Month 16 booster dose of Synflorix™
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RTS,S Regimen A Group Engerix B Regimen A Group
    Number of subjects analysed
    133
    126
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        EL.U/mL
    2648.3 (2194.2 to 3196.4)
    2819.1 (2391.1 to 3323.7)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against acellular B-pertussis (BPT)

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    End point title
    		 Concentrations of antibodies against acellular B-pertussis (BPT)
    End point description
    The antibodies against BPT assessed were against pertussis toxoid (anti-PT), against filamentous haemagglutinin (anti-FHA), and against pertactin (anti-PRN). Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to (>=) 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    At Day 0 and at Month 3 (one month post Dose 3 of Infanrix™-Hib)
    End point values
    		 RTS,S Group Engerix B Group
    Number of subjects analysed
    401
    253
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT – At Day 0
    3.8 (3.6 to 4.1)
    4.3 (3.9 to 4.8)
        Anti-PT – At Month 3
    105.9 (99.2 to 113.1)
    114.2 (104.8 to 124.5)
        Anti-FHA – At Day 0
    13.9 (12.7 to 15.2)
    15.7 (14.1 to 17.5)
        Anti-FHA – At Month 3
    271.1 (252.8 to 290.8)
    292.9 (268.9 to 319.1)
        Anti-PRN – At Day 0
    3.2 (3 to 3.4)
    3.2 (3 to 3.5)
        Anti-PRN – At Month 3
    164.1 (153.6 to 175.3)
    179.7 (164.4 to 196.5)
    No statistical analyses for this end point

    Secondary: Anti-Rotavirus (anti-RV) antibody concentrations

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    End point title
    		 Anti-Rotavirus (anti-RV) antibody concentrations [11]
    End point description
    Anti-Rotavirus (anti-RV) antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs). The cut-off of the assay was the seropositive cut-off value of greater than or equal to (>=) 20 units per milliliter (U/mL). This outcome measure was assessed in subjects who were administered Rotarix™ as part of an EPI regimen, with and without RTS,S vaccine co-administration. This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Rotarix™. Results presented are for the study groups pooled by RTS,S or Engerix-B™ vaccine co-administration, that is, for the RTS,S Regimen B and Engerix-B Regimen B groups.
    End point type
    Secondary
    End point timeframe
    At Month 3, aka one month post Dose 2 of Rotarix™
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RTS,S Regimen B Group Engerix B Regimen B Group
    Number of subjects analysed
    120
    116
    Units: U/mL
    geometric mean (confidence interval 95%)
        U/mL
    24.9 (19.3 to 32)
    27.6 (20.8 to 36.5)
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling at the site of injection. All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination. Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B™ (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited local symptoms, that is, the occurrences of these symptoms regardless of their intensity grade.
    End point type
    Secondary
    End point timeframe
    Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B™ vaccine
    End point values
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
    Number of subjects analysed
    142
    142
    141
    141
    139
    Units: Subject
        Pain - Post D1
    41
    28
    31
    29
    15
        Pain – Post D2
    30
    14
    21
    24
    9
        Pain – Post D3
    14
    10
    14
    18
    7
        Redness – Post D1
    1
    0
    2
    5
    1
        Redness – Post D2
    5
    1
    2
    3
    0
        Redness – Post D3
    3
    0
    1
    3
    0
        Swelling – Post D1
    5
    2
    6
    10
    4
        Swelling – Post D2
    8
    3
    4
    9
    4
        Swelling – Post D3
    7
    2
    6
    11
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms
    End point description
    Assessed solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Fever was defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B™ (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited general symptoms, that is, the occurrences of these symptoms regardless of their intensity grade or relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B™ vaccine
    End point values
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
    Number of subjects analysed
    142
    142
    141
    141
    139
    Units: Subject
        Fever – D1
    44
    20
    16
    23
    13
        Fever – D2
    30
    14
    18
    20
    5
        Fever – D3
    38
    20
    26
    16
    12
        Irritability – D1
    15
    11
    11
    9
    5
        Irritability – D2
    13
    7
    12
    10
    0
        Irritability – D3
    5
    3
    10
    6
    1
        Drowsiness – D1
    2
    1
    3
    3
    0
        Drowsiness – D2
    5
    1
    1
    3
    0
        Drowsiness – D3
    3
    0
    2
    1
    0
        Loss of appetite – D1
    4
    1
    2
    4
    0
        Loss of appetite – D2
    3
    1
    1
    3
    0
        Loss of appetite – D3
    2
    0
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with potential immune mediated disorders (pIMDs)

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    End point title
    		 Number of subjects with potential immune mediated disorders (pIMDs)
    End point description
    A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.
    End point type
    Secondary
    End point timeframe
    From Day 0 to Month 8.
    End point values
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
    Number of subjects analysed
    142
    142
    141
    141
    139
    Units: Subject
        Subject
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with potential immune mediated disorders (pIMDs)

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    End point title
    		 Number of subjects with potential immune mediated disorders (pIMDs)
    End point description
    A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.
    End point type
    Secondary
    End point timeframe
    From study start at Day 0 to Month 26
    End point values
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
    Number of subjects analysed
    142
    142
    141
    141
    139
    Units: Subject
        Subject
    0
    0
    0
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
    End point type
    Secondary
    End point timeframe
    Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B™
    End point values
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
    Number of subjects analysed
    142
    142
    141
    141
    139
    Units: Subject
        Subject
    121
    115
    120
    120
    105
    No statistical analyses for this end point

    Secondary: Number of subjects with any and fatal serious adverse events (SAEs)

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    End point title
    		 Number of subjects with any and fatal serious adverse events (SAEs)
    End point description
    A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.
    End point type
    Secondary
    End point timeframe
    Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B™
    End point values
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
    Number of subjects analysed
    142
    142
    141
    141
    139
    Units: Subject
        Subject with SAE(s)
    1
    3
    3
    1
    3
        Subjects with fatal SAE(s)
    1
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any and fatal serious adverse events (SAEs)

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    End point title
    		 Number of subjects with any and fatal serious adverse events (SAEs)
    End point description
    A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.
    End point type
    Secondary
    End point timeframe
    From Day 0 to Month 8
    End point values
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
    Number of subjects analysed
    142
    142
    141
    141
    139
    Units: Subject
        Subjects with SAE(s)
    1
    7
    7
    3
    5
        Subjects with fatal SAE(s)
    1
    2
    2
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any and fatal serious adverse events (SAEs)

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    End point title
    		 Number of subjects with any and fatal serious adverse events (SAEs)
    End point description
    A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.
    End point type
    Secondary
    End point timeframe
    From Day 0 to Month 26
    End point values
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
    Number of subjects analysed
    142
    142
    141
    141
    139
    Units: Subject
        Any SAEs - At Month 26
    1
    8
    7
    6
    6
        Fatal SAEs - At Month 26
    1
    3
    2
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local, general symptoms and Unsolicited AEs: Within the 30-day periods after primary vaccination. SAEs: Within the 30-day periods after primary vaccination and from Day 0 to Month 26.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    RTS,S Regimen A Group
    Reporting group description
    		 This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group title
    RTS,S Regimen B Group
    Reporting group description
    		 This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group title
    RTS,S Regimen C Group
    Reporting group description
    		 This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group title
    Engerix B Regimen B Group
    Reporting group description
    		 Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Reporting group title
    Engerix B Regimen A Group
    Reporting group description
    		 Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.

    Serious adverse events
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen B Group Engerix B Regimen A Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 142 (0.70%)
    7 / 142 (4.93%)
    7 / 141 (4.96%)
    5 / 139 (3.60%)
    3 / 141 (2.13%)
         number of deaths (all causes)
    1
    3
    2
    1
    2
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
    0 / 141 (0.00%)
    0 / 139 (0.00%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 142 (0.00%)
    1 / 141 (0.71%)
    0 / 139 (0.00%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
    1 / 141 (0.71%)
    1 / 139 (0.72%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 142 (0.00%)
    0 / 141 (0.00%)
    1 / 139 (0.72%)
    1 / 141 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
    1 / 141 (0.71%)
    0 / 139 (0.00%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 142 (0.70%)
    2 / 141 (1.42%)
    1 / 139 (0.72%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
    1 / 141 (0.71%)
    1 / 139 (0.72%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
    1 / 141 (0.71%)
    1 / 139 (0.72%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 142 (0.00%)
    1 / 141 (0.71%)
    0 / 139 (0.00%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 142 (0.00%)
    0 / 141 (0.00%)
    1 / 139 (0.72%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fungal infection
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
    0 / 141 (0.00%)
    0 / 139 (0.00%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 142 (1.41%)
    2 / 141 (1.42%)
    1 / 139 (0.72%)
    2 / 141 (1.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Trichomoniasis intestinal
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
    0 / 141 (0.00%)
    0 / 139 (0.00%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
    0 / 141 (0.00%)
    0 / 139 (0.00%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Failure to thrive
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
    0 / 141 (0.00%)
    0 / 139 (0.00%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
    0 / 141 (0.00%)
    0 / 139 (0.00%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen B Group Engerix B Regimen A Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    129 / 142 (90.85%)
    123 / 142 (86.62%)
    128 / 141 (90.78%)
    114 / 139 (82.01%)
    132 / 141 (93.62%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    8 / 142 (5.63%)
    2 / 142 (1.41%)
    6 / 141 (4.26%)
    0 / 139 (0.00%)
    7 / 141 (4.96%)
         occurrences all number
    10
    2
    5
    0
    5
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    55 / 142 (38.73%)
    40 / 142 (28.17%)
    47 / 141 (33.33%)
    25 / 139 (17.99%)
    48 / 141 (34.04%)
         occurrences all number
    85
    52
    66
    32
    71
    Swelling
         subjects affected / exposed
    17 / 142 (11.97%)
    7 / 142 (4.93%)
    14 / 141 (9.93%)
    10 / 139 (7.19%)
    23 / 141 (16.31%)
         occurrences all number
    20
    7
    16
    11
    30
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    81 / 142 (57.04%)
    49 / 142 (34.51%)
    50 / 141 (35.46%)
    34 / 139 (24.46%)
    55 / 141 (39.01%)
         occurrences all number
    116
    56
    66
    37
    65
    Eye disorders
    Conjunctivitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 142 (5.63%)
    10 / 142 (7.04%)
    11 / 141 (7.80%)
    7 / 139 (5.04%)
    9 / 141 (6.38%)
         occurrences all number
    8
    10
    12
    7
    10
    Skin and subcutaneous tissue disorders
    Erythema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    19 / 142 (13.38%)
    8 / 142 (5.63%)
    20 / 141 (14.18%)
    6 / 139 (4.32%)
    12 / 141 (8.51%)
         occurrences all number
    19
    8
    20
    6
    13
    Psychiatric disorders
    Irritability / fussiness
         subjects affected / exposed
    28 / 142 (19.72%)
    18 / 142 (12.68%)
    27 / 141 (19.15%)
    5 / 139 (3.60%)
    19 / 141 (13.48%)
         occurrences all number
    33
    21
    33
    6
    25
    Infections and infestations
    Malaria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    44 / 142 (30.99%)
    44 / 142 (30.99%)
    39 / 141 (27.66%)
    44 / 139 (31.65%)
    48 / 141 (34.04%)
         occurrences all number
    50
    54
    46
    53
    51
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    42 / 142 (29.58%)
    47 / 142 (33.10%)
    51 / 141 (36.17%)
    38 / 139 (27.34%)
    43 / 141 (30.50%)
         occurrences all number
    55
    58
    71
    47
    57
    Rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    32 / 142 (22.54%)
    35 / 142 (24.65%)
    33 / 141 (23.40%)
    31 / 139 (22.30%)
    31 / 141 (21.99%)
         occurrences all number
    37
    41
    41
    36
    36
    Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    36 / 142 (25.35%)
    33 / 142 (23.24%)
    28 / 141 (19.86%)
    29 / 139 (20.86%)
    28 / 141 (19.86%)
         occurrences all number
    47
    35
    35
    37
    31
    Pharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    23 / 142 (16.20%)
    13 / 142 (9.15%)
    15 / 141 (10.64%)
    17 / 139 (12.23%)
    14 / 141 (9.93%)
         occurrences all number
    24
    15
    19
    18
    17
    Otitis media
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 142 (7.75%)
    12 / 142 (8.45%)
    6 / 141 (4.26%)
    10 / 139 (7.19%)
    15 / 141 (10.64%)
         occurrences all number
    11
    13
    6
    11
    19
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    15 / 142 (10.56%)
    8 / 142 (5.63%)
    12 / 141 (8.51%)
    7 / 139 (5.04%)
    8 / 141 (5.67%)
         occurrences all number
    17
    9
    15
    10
    9
    Respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 142 (4.23%)
    8 / 142 (5.63%)
    14 / 141 (9.93%)
    6 / 139 (4.32%)
    8 / 141 (5.67%)
         occurrences all number
    6
    8
    17
    7
    9
    Fungal skin infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 142 (0.70%)
    7 / 142 (4.93%)
    6 / 141 (4.26%)
    4 / 139 (2.88%)
    12 / 141 (8.51%)
         occurrences all number
    1
    7
    6
    4
    12
    Bronchiolitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 142 (6.34%)
    5 / 142 (3.52%)
    5 / 141 (3.55%)
    4 / 139 (2.88%)
    4 / 141 (2.84%)
         occurrences all number
    8
    5
    5
    4
    4
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 142 (3.52%)
    14 / 142 (9.86%)
    4 / 141 (2.84%)
    2 / 139 (1.44%)
    11 / 141 (7.80%)
         occurrences all number
    5
    15
    4
    2
    11

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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.
    None reported
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