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    Clinical Trial Results:
    A Phase II randomized, open, controlled study of the safety and immunogenicity of GlaxoSmithKline Biologicals’ candidate Plasmodium falciparum malaria vaccine RTS,S/AS01E, when incorporated into an Expanded Program on Immunization (EPI) regimen that includes DTPwHepB/Hib, OPV, measles and yellow fever vaccination in infants living in malaria-endemic regions.

    Summary
    EudraCT number
    		 2012-005695-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    07 Oct 2009

    Results information
    Results version number
    		 v3(current)
    This version publication date
    22 Nov 2020
    First version publication date
    18 Jul 2015
    Other versions
    		 v1 (removed from public view) , v2
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    106369
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00436007
    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, 44 208990 4466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 208990 4466, 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
    09 Jul 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Oct 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety (SAEs) of RTS,S/AS01E when co-administered on a 0, 1, 2-month schedule with DTPwHepB/Hib and OPV at 6, 10 and 14 weeks of age, until 6 months post Dose 3 of RTS,S/AS01E (study Month 8), and when co-administered on a 0, 1, 7-month schedule with DTPwHepB/Hib and OPV at 6 and 10 weeks of age then with measles and yellow fever vaccination at 9 months of age, until one month post Dose 3 of RTS,S/AS01E (study Month 8).
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up for safety events from the time the subject consents to participate in the study until she/he is discharged. Subjects were also followed-up as regards infection with malaria, by passive case detection (PCD). Parents were advised to present their child to a health facility within the study area when he/she was unwell. When a subject was presented to a health facility within a study area, he/she was reviewed by clinically qualified personnel and treated as required. The temperature was recorded and if  37.5C, a blood slide was performed to test for malari infection. A rapid test was performed to guide immediate patient management, when assessed as needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 11 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: 210
    Country: Number of subjects enrolled
    Gabon: 220
    Country: Number of subjects enrolled
    Ghana: 81
    Worldwide total number of subjects
    511
    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)
    511
    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

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study comprised a vaccination phase (Months 0-8) and a follow-up phase (Months 8-19). The Stamaril vaccine was not part of the EPI Tanzanian vaccination schedule at study planning. Hence this vaccine was not administered to subjects from Tanzania.

    Pre-assignment period milestones
    Number of subjects started
    		 511
    Number of subjects completed
    		 511

    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
    		 GSK 257049 1 Group
    Arm description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix HepB/Hib, Polio Sabin and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax and Stamaril vaccines at Month 7. The GSK 257049 and Tritanrix HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax and Stamaril were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Candidate Plasmodium falciparum malaria vaccine
    Investigational medicinal product code
    RTS,S+AS01E
    Other name
    RTS,S, GSK 257049
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the left antero-lateral thigh at specified timepoints (see group description details).

    Investigational medicinal product name
    Rouvax
    Investigational medicinal product code
    Other name
    AMV, Rouvax
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use, Subcutaneous use
    Dosage and administration details
    Intramuscular administration in the left arm at specified timepoints (see group description details).

    Investigational medicinal product name
    Stamaril
    Investigational medicinal product code
    Other name
    Yellow Fever Vaccine (YFV), Stamaril
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the right arm at specified timepoints (see group description details).

    Investigational medicinal product name
    Polio Sabin (Oral)
    Investigational medicinal product code
    Other name
    Polio Sabin, Oral Polio vaccine (OPV)
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Oral administration at specified time points (see group description details)

    Investigational medicinal product name
    DTPw-HBV
    Investigational medicinal product code
    Other name
    Tritanrix HepB,TritanrixTM-HepB
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the right antero-lateral thigh at specified time points (see group description details)

    Investigational medicinal product name
    Hiberix
    Investigational medicinal product code
    Other name
    Hib, HiberixTM
    Pharmaceutical forms
    Powder and solvent for solution for injection/skin-prick test
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the right antero-lateral thigh at specified time points (see group description details)

    Arm title
    		 GSK 257049 2 Group
    Arm description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix HepB/Hib, and Polio Sabin at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax and Stamaril at Month 7. The GSK 257049 and Tritanrix HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax and Stamaril were administered intramuscularly in the left and right arm respectively. Polio Sabin was administered orally. Stamaril was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Candidate Plasmodium falciparum malaria vaccine
    Investigational medicinal product code
    RTS,S+AS01E
    Other name
    RTS,S, GSK 257049
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the left antero-lateral thigh at specified timepoints (see group description details).

    Investigational medicinal product name
    Rouvax
    Investigational medicinal product code
    Other name
    AMV, Rouvax
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use, Subcutaneous use
    Dosage and administration details
    Intramuscular administration in the left arm at specified timepoints (see group description details).

    Investigational medicinal product name
    Stamaril
    Investigational medicinal product code
    Other name
    Yellow Fever Vaccine (YFV), Stamaril
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the right arm at specified timepoints (see group description details).

    Investigational medicinal product name
    Polio Sabin (Oral)
    Investigational medicinal product code
    Other name
    Polio Sabin, Oral Polio vaccine (OPV)
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Oral administration at specified time points (see group description details)

    Investigational medicinal product name
    DTPw-HBV
    Investigational medicinal product code
    Other name
    Tritanrix HepB,TritanrixTM-HepB
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the right antero-lateral thigh at specified time points (see group description details)

    Investigational medicinal product name
    Hiberix
    Investigational medicinal product code
    Other name
    Hib, HiberixTM
    Pharmaceutical forms
    Powder and solvent for solution for injection/skin-prick test
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the right antero-lateral thigh at specified time points (see group description details)

    Arm title
    		 Tritanrix HepB/Hiberix Group
    Arm description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix HepB/Hib, and Polio Sabin at Months 0, 1 and 2, and a single dose of Rouvax and Stamaril at Month 7. The GSK 257049 and Tritanrix HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax and Stamaril were administered intramuscularly in the left and right arm respectively. Polio Sabin was administered orally. The Stamaril vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Rouvax
    Investigational medicinal product code
    Other name
    AMV, Rouvax
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use, Subcutaneous use
    Dosage and administration details
    Intramuscular administration in the left arm at specified timepoints (see group description details).

    Investigational medicinal product name
    Stamaril
    Investigational medicinal product code
    Other name
    Yellow Fever Vaccine (YFV), Stamaril
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the right arm at specified timepoints (see group description details).

    Investigational medicinal product name
    Polio Sabin (Oral)
    Investigational medicinal product code
    Other name
    Polio Sabin, Oral Polio vaccine (OPV)
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Oral administration at specified time points (see group description details)

    Investigational medicinal product name
    DTPw-HBV
    Investigational medicinal product code
    Other name
    Tritanrix HepB,TritanrixTM-HepB
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the right antero-lateral thigh at specified time points (see group description details)

    Investigational medicinal product name
    Hiberix
    Investigational medicinal product code
    Other name
    Hib, HiberixTM
    Pharmaceutical forms
    Powder and solvent for solution for injection/skin-prick test
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the right antero-lateral thigh at specified time points (see group description details)

    Number of subjects in period 1
    		GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Started
    170
    170
    171
    Completed
    151
    156
    148
    Not completed
    19
    14
    23
         Consent withdrawn by subject
    5
    3
    4
         Physician decision
    -
    -
    2
         Death
    -
    1
    3
         Unspecified
    -
    -
    1
         Lost to follow-up
    14
    10
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK 257049 1 Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix HepB/Hib, Polio Sabin and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax and Stamaril vaccines at Month 7. The GSK 257049 and Tritanrix HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax and Stamaril were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

    Reporting group title
    GSK 257049 2 Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix HepB/Hib, and Polio Sabin at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax and Stamaril at Month 7. The GSK 257049 and Tritanrix HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax and Stamaril were administered intramuscularly in the left and right arm respectively. Polio Sabin was administered orally. Stamaril was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

    Reporting group title
    Tritanrix HepB/Hiberix Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix HepB/Hib, and Polio Sabin at Months 0, 1 and 2, and a single dose of Rouvax and Stamaril at Month 7. The GSK 257049 and Tritanrix HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax and Stamaril were administered intramuscularly in the left and right arm respectively. Polio Sabin was administered orally. The Stamaril vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

    Reporting group values
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group Total
    Number of subjects
    		 170 170 171 511
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 170 170 171 511
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 7 ( 0.97 ) 7.1 ( 1.05 ) 7 ( 0.97 ) -
    Gender categorical
    Units: Subjects
        Female
    		 90 84 78 252
        Male
    		 80 86 93 259

    End points

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    End points reporting groups
    Reporting group title
    GSK 257049 1 Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix HepB/Hib, Polio Sabin and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax and Stamaril vaccines at Month 7. The GSK 257049 and Tritanrix HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax and Stamaril were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

    Reporting group title
    GSK 257049 2 Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix HepB/Hib, and Polio Sabin at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax and Stamaril at Month 7. The GSK 257049 and Tritanrix HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax and Stamaril were administered intramuscularly in the left and right arm respectively. Polio Sabin was administered orally. Stamaril was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

    Reporting group title
    Tritanrix HepB/Hiberix Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix HepB/Hib, and Polio Sabin at Months 0, 1 and 2, and a single dose of Rouvax and Stamaril at Month 7. The GSK 257049 and Tritanrix HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax and Stamaril were administered intramuscularly in the left and right arm respectively. Polio Sabin was administered orally. The Stamaril vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

    Primary: Number of subjects with serious adverse events (SAEs).

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    End point title
    		 Number of subjects with serious adverse events (SAEs). [1]
    End point description
    SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
    End point type
    Primary
    End point timeframe
    From Month 0 to Month 8
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    170
    170
    171
    Units: Subjects
        Subjects with any SAE(s)
    38
    28
    33
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against hepatitis B (Anti-HB antibodies).

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    End point title
    		 Concentrations of antibodies against hepatitis B (Anti-HB antibodies). [2]
    End point description
    Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 1 Group.
    End point type
    Secondary
    End point timeframe
    At Months 0, 1, 3 and 7
    Notes
    [2] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    		 GSK 257049 1 Group
    Number of subjects analysed
    145
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HB, Month 0 [N=145]
    12.5 (9.9 to 15.7)
        Anti-HB, Month 1 [N=133]
    173.4 (131.9 to 228)
        Anti-HB, Month 3 [N=130]
    1355.7 (1100.6 to 1669.9)
        Anti-HB, Month 7 [N=137]
    1555.5 (1315.8 to 1839)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against hepatitis B (Anti-HB antibodies).

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    End point title
    		 Concentrations of antibodies against hepatitis B (Anti-HB antibodies). [3]
    End point description
    Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 2 Group.
    End point type
    Secondary
    End point timeframe
    At Months 0, 3, 7 and 8
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    		 GSK 257049 2 Group
    Number of subjects analysed
    131
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HB, Month 0 [N=131]
    9.6 (7.8 to 11.8)
        Anti-HB, Month 3 [N=119]
    651.2 (541.1 to 783.8)
        Anti-HB, Month 7 [N=126]
    1133.1 (972.3 to 1320.6)
        Anti-HB, Month 8 [N=125]
    59813.5 (47050.5 to 76038.6)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against hepatitis B (Anti-HB antibodies).

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    End point title
    		 Concentrations of antibodies against hepatitis B (Anti-HB antibodies). [4]
    End point description
    Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the Tritanrix HepB/Hiberix Group.
    End point type
    Secondary
    End point timeframe
    At Months 0, 3, 7 and 8
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    		 Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    143
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HB, Month 0 [N=143]
    8.7 (7.3 to 10.5)
        Anti-HB, Month 3 [N=126]
    338 (266.3 to 429)
        Anti-HB, Month 7 [N=131]
    159.9 (127 to 201.3)
        Anti-HB, Month 8 [N=133]
    162.4 (127.9 to 206.3)
    No statistical analyses for this end point

    Secondary: Concentrations of anti-diphtheria (Anti-D) and anti-tetanus (Anti-T) antibodies.

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    End point title
    		 Concentrations of anti-diphtheria (Anti-D) and anti-tetanus (Anti-T) antibodies.
    End point description
    Anti-D and Anti-T antibody concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection assay cut-off was 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 3
    End point values
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    142
    133
    142
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D
    1 (0.9 to 1.2)
    1.1 (0.9 to 1.3)
    1.4 (1.2 to 1.7)
        Anti-T
    2.8 (2.3 to 3.3)
    2.6 (2.2 to 3.1)
    3.7 (3.2 to 4.3)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs).
    End point description
    SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From Month 8 to Month 19
    End point values
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    170
    170
    171
    Units: Subjects
        Subjects with any SAE(s)
    28
    24
    27
    No statistical analyses for this end point

    Secondary: Concentrations of anti-polyribosyl ribitol phosphate (Anti-PRP) antibodies.

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    End point title
    		 Concentrations of anti-polyribosyl ribitol phosphate (Anti-PRP) antibodies.
    End point description
    Anti-PRP antibody concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection assay cut-off was 0.15 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 3
    End point values
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    141
    132
    142
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP
    13.3 (10.5 to 16.7)
    15.7 (12.6 to 19.4)
    18.6 (14.8 to 23.5)
    No statistical analyses for this end point

    Secondary: Titers for antibodies against poliomyelitis types 1, 2 and 3 (Anti-Polio 1, 2 and 3 antibodies).

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    End point title
    		 Titers for antibodies against poliomyelitis types 1, 2 and 3 (Anti-Polio 1, 2 and 3 antibodies).
    End point description
    Anti-Polio 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 8.
    End point type
    Secondary
    End point timeframe
    At Month 3
    End point values
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    136
    125
    133
    Units: titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1 [N=136;125;131]
    463.6 (342.8 to 627)
    485.5 (342.5 to 688.3)
    500 (365 to 684.9)
        Anti-Polio 2 [N=135;124;131]
    494 (389.7 to 626.2)
    563.2 (457.3 to 693.6)
    406.8 (329.1 to 502.9)
        Anti-Polio 3 [N=135;125;133]
    123.5 (92.1 to 165.6)
    148.7 (112.2 to 197)
    205.1 (156.5 to 268.7)
    No statistical analyses for this end point

    Secondary: Concentrations of anti-Bordetella pertussis toxin (Anti-BPT) antibodies.

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    End point title
    		 Concentrations of anti-Bordetella pertussis toxin (Anti-BPT) antibodies.
    End point description
    Anti-BPT antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 15 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    At Month 3
    End point values
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    139
    131
    139
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-BPT
    85.3 (76.8 to 94.6)
    104.4 (94.8 to 115)
    106.5 (96.1 to 118.1)
    No statistical analyses for this end point

    Secondary: Concentrations of anti-measles antibodies.

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    End point title
    		 Concentrations of anti-measles antibodies. [5]
    End point description
    Anti-measles antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seropositivity assay cut-off was 150 mIU/mL. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix HepB/Hiberix groups.
    End point type
    Secondary
    End point timeframe
    At Months 7 and 8
    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: Due to different number of vaccine doses administered, the results for the three groups were presented separately.
    End point values
    		 GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    119
    122
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-measles, Month 7 [N=112;120]
    75 (75 to 75)
    1295.2 (1052.1 to 1594.5)
        Anti-measles, Month 8 [N=119;122]
    76.2 (73.8 to 78.6)
    1299 (1038.8 to 1624.4)
    No statistical analyses for this end point

    Secondary: Titers for anti-yellow fever antibodies.

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    End point title
    		 Titers for anti-yellow fever antibodies. [6]
    End point description
    Anti-yellow fever antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 10. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix HepB/Hiberix groups.
    End point type
    Secondary
    End point timeframe
    At Months 7 and 8.
    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: Due to different number of vaccine doses administered, the results for the three groups were presented separately.
    End point values
    		 GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    62
    64
    Units: titers
    geometric mean (confidence interval 95%)
        Anti-yellow fever, Month 7 [N=41;62]
    5.3 (4.8 to 5.8)
    5.9 (5.1 to 6.9)
        Anti-yellow fever, Month 8 [N=46;64]
    172.2 (135.9 to 236.3)
    183.4 (134 to 250.9)
    No statistical analyses for this end point

    Secondary: Concentrations of anti-circumsporozoite protein (Anti-CS) antibodies.

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    End point title
    		 Concentrations of anti-circumsporozoite protein (Anti-CS) antibodies. [7]
    End point description
    Anti-CS antibody antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 1 Group.
    End point type
    Secondary
    End point timeframe
    At Months 0, 1, 3 and 7
    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: Due to different number of vaccine doses administered, the results for the three groups were presented separately.
    End point values
    		 GSK 257049 1 Group
    Number of subjects analysed
    153
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-CS, Month 0 [N=153]
    0.4 (0.3 to 0.4)
        Anti-CS, Month 2 [N=137]
    86.6 (66.5 to 112.7)
        Anti-CS, Month 3 [N=131]
    190.3 (154.3 to 234.7)
        Anti-CS, Month 7 [N=137]
    35.3 (28.5 to 43.8)
    No statistical analyses for this end point

    Secondary: Concentrations of anti-circumsporozoite protein (Anti-CS) antibodies.

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    End point title
    		 Concentrations of anti-circumsporozoite protein (Anti-CS) antibodies. [8]
    End point description
    Anti-CS antiibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 2 Group.
    End point type
    Secondary
    End point timeframe
    At Months 0, 3, 7 and 8
    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: Due to different number of vaccine doses administered, the results for the three groups were presented separately.
    End point values
    		 GSK 257049 2 Group
    Number of subjects analysed
    141
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-CS, Month 0 [N=141]
    0.4 (0.3 to 0.4)
        Anti-CS, Month 3 [N=121]
    57.7 (43.7 to 76.2)
        Anti-CS, Month 7 [N=127]
    6.1 (4.6 to 7.9)
        Anti-CS, Month 8 [N=127]
    107.8 (81.1 to 143.4)
    No statistical analyses for this end point

    Secondary: Concentrations of anti-circumsporozoite protein (Anti-CS) antibodies.

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    End point title
    		 Concentrations of anti-circumsporozoite protein (Anti-CS) antibodies. [9]
    End point description
    Anti-CS antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the Tritanrix HepB/Hiberix Group.
    End point type
    Secondary
    End point timeframe
    At Months 0, 3, 7 and 8
    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: Due to different number of vaccine doses administered, the results for the three groups were presented separately.
    End point values
    		 Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    156
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-CS, Month 0 [N=156]
    0.4 (0.3 to 0.4)
        Anti-CS, Month 3 [N=129]
    0.3 (0.3 to 0.3)
        Anti-CS, Month 7 [N=132]
    0.3 (0.3 to 0.3)
        Anti-CS, Month 8 [N=135]
    0.3 (0.3 to 0.3)
    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 and swelling at injection site following vaccination with each of the following study vaccines administered intramuscularly, e. a. the Tritanrix HepB/Hib, Rouvax, GSK 257049 and Stamaril vaccines. The numbers of subjects with each of the assessed solicited local symptoms reported were tabulated for each vaccine administered, separately. The GSK 257049 vaccine was not administered to subjects from the Tritanrix HepB/Hiberix Group.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) follow-up period after any vaccination with the Tritanrix HepB/Hib, Rouvax, GSK 257049 and Stamaril vaccines
    End point values
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    170
    170
    171
    Units: Subjects
        Pain - GSK 257049 [N=170;170;0]
    126
    116
    0
        Swelling - GSK 257049 [N=170;170;0]
    28
    44
    0
        Pain - Rouvax [N=163;161;159]
    52
    54
    47
        Swelling - Rouvax [N=163;161;159]
    20
    21
    16
        Pain - Stamaril [N=95;94;94]
    2
    7
    2
        Swelling - Stamaril [N=95;94;94]
    0
    1
    0
        Pain - Tritanrix HepB/Hib [N=170;170;171]
    127
    133
    140
        Swelling - Tritanrix HepB/Hib [N=170;170;171]
    47
    68
    68
    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 drowsiness, fever [axillary temperature equal or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite following any vaccination with any of the study vaccines, e. a. the Tritanrix HepB/Hib, Rouvax, GSK 257049, Stamaril and Polio Sabin vaccines.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) follow-up period after any vaccination
    End point values
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    170
    170
    171
    Units: Subjects
        Drowsiness
    82
    97
    72
        Fever (axillary temperature ≥ 37.5°C)
    102
    95
    75
        Irritability
    124
    131
    118
        Loss of appetite
    68
    83
    70
    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 is any AE (i.e. any 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. Unsolicited AEs were assessed following vaccination with any of the study vaccines, e. a. the Tritanrix HepB/Hib, Rouvax, GSK 257049, Stamaril and Polio Sabin vaccines.
    End point type
    Secondary
    End point timeframe
    During the 30-day (Days 0-29) follow-up period after any vaccination
    End point values
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    170
    170
    171
    Units: Subjects
        Subjects with any AE(s)
    160
    161
    164
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs).
    End point description
    SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 19
    End point values
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Number of subjects analysed
    170
    170
    171
    Units: Subjects
        Subjects with any SAE(s)
    57
    47
    49
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs: Months [M] 0-19, as specified for each event; Solicited local/general & Unsolicited AEs: 7- and 30-day post-vaccination periods, respectively. “1” was entered as n at risk if a group is not concerned by a specified event.
    Adverse event reporting additional description
    The all/related reported AEs occurrence was not available and is encoded as equal to the number of subjects affected. One subject from GSK 257049 2 Group died due to SAEs (gastroenteritis, severe dehydration), the event was reported late to sponsor. Subject was reported lost to follow up and the death occurred after the last study visit due date.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    GSK 257049 1 Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix HepB/Hib, Polio Sabin and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax and Stamaril vaccines at Month 7. The GSK 257049 and Tritanrix HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax and Stamaril were administered intramuscularly in the left and right arm respectively. Polio Sabin was administered orally. The Stamaril vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

    Reporting group title
    GSK 257049 2 Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix HepB/Hib, and Polio Sabin at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax and Stamaril at Month 7. The GSK 257049 and Tritanrix HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax and Stamaril were administered intramuscularly in the left and right arm respectively. Polio Sabin was administered orally. Stamaril was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

    Reporting group title
    Tritanrix HepB/Hiberix Group
    Reporting group description
    		 Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix HepB/Hib, and Polio Sabin at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax and Stamaril at Month 7. The GSK 257049 and Tritanrix HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax and Stamaril were administered intramuscularly in the left and right arm respectively. Polio Sabin was administered orally. Stamaril was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

    Serious adverse events
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    57 / 170 (33.53%)
    47 / 170 (27.65%)
    49 / 171 (28.65%)
         number of deaths (all causes)
    0
    0
    3
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia (M0 to 8)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Pyrexia (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity (M0 to8)
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    2 / 170 (1.18%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Thermal burn (M8 to 19)
         subjects affected / exposed
    2 / 170 (1.18%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Accidental exposure (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Petroleum distillate poisoning (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis chemical (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Sickle cell anaemia (M0-8)
         subjects affected / exposed
    1 / 170 (0.59%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sickle cell anaemia with crisis (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract congenital (M0 to 8)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sickle cell anaemia with crisis (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    4 / 170 (2.35%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion (M0 to 8)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    2 / 170 (1.18%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia (M0 to 8)
         subjects affected / exposed
    6 / 170 (3.53%)
    10 / 170 (5.88%)
    10 / 171 (5.85%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 10
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Microcytic anaemia (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia (M8 to 19)
         subjects affected / exposed
    6 / 170 (3.53%)
    6 / 170 (3.53%)
    10 / 171 (5.85%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Microcytic anaemia (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 170 (0.59%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemolytic anaemia (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Blepharitis (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conjunctivitis (M0 to 8)
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enteritis (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    1 / 170 (0.59%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Glomerulonephritis (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis (M0 to 8)
         subjects affected / exposed
    17 / 170 (10.00%)
    10 / 170 (5.88%)
    14 / 171 (8.19%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 10
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plasmodium falciparum infection (M0-8)
         subjects affected / exposed
    5 / 170 (2.94%)
    10 / 170 (5.88%)
    13 / 171 (7.60%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pneumonia (M0 to 8)
         subjects affected / exposed
    11 / 170 (6.47%)
    9 / 170 (5.29%)
    8 / 171 (4.68%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Upper respiratory tract infection (M0 to 8)
         subjects affected / exposed
    5 / 170 (2.94%)
    4 / 170 (2.35%)
    4 / 171 (2.34%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impetigo (M0 to 8)
         subjects affected / exposed
    4 / 170 (2.35%)
    0 / 170 (0.00%)
    3 / 171 (1.75%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis (M0 to 8)
         subjects affected / exposed
    2 / 170 (1.18%)
    2 / 170 (1.18%)
    3 / 171 (1.75%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection (M0 to 8)
         subjects affected / exposed
    3 / 170 (1.76%)
    2 / 170 (1.18%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media (M0 to 8)
         subjects affected / exposed
    3 / 170 (1.76%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acarodermatitis (M0 to 8)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    2 / 171 (1.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salmonella sepsis (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acquired immunodeficiency syndrome (M0 to 8)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Extrapulmonary tuberculosis (M0 to 8)
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydrocele male infected (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis (M0 to 8)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute (M0 to 8)
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periorbital abscess (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis (M0 to 8)
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhinitis (M0 to 8)
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin infection (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plasmodium falciparum infection (M8 to 19)
         subjects affected / exposed
    6 / 170 (3.53%)
    6 / 170 (3.53%)
    14 / 171 (8.19%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pneumonia (M8 to 19)
         subjects affected / exposed
    5 / 170 (2.94%)
    7 / 170 (4.12%)
    7 / 171 (4.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Upper respiratory tract infection (M8 to 19)
         subjects affected / exposed
    7 / 170 (4.12%)
    4 / 170 (2.35%)
    5 / 171 (2.92%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis (M8 to 19)
         subjects affected / exposed
    7 / 170 (4.12%)
    6 / 170 (3.53%)
    2 / 171 (1.17%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impetigo (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    3 / 170 (1.76%)
    3 / 171 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis (M8 to 19)
         subjects affected / exposed
    3 / 170 (1.76%)
    2 / 170 (1.18%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection (M8 to 19)
         subjects affected / exposed
    3 / 170 (1.76%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    2 / 171 (1.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Bronchopneumonia (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    2 / 171 (1.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acquired immunodeficiency syndrome (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Dysentery (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media chronic (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin infection (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 170 (0.59%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration (M0 to 8)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malnutrition (M0 to 8)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malnutrition (M8 to 19)
         subjects affected / exposed
    2 / 170 (1.18%)
    1 / 170 (0.59%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Dehydration (M8 to 19)
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive (M8 to 19)
         subjects affected / exposed
    0 / 170 (0.00%)
    0 / 170 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK 257049 1 Group GSK 257049 2 Group Tritanrix HepB/Hiberix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    169 / 170 (99.41%)
    169 / 170 (99.41%)
    171 / 171 (100.00%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    11 / 170 (6.47%)
    19 / 170 (11.18%)
    11 / 171 (6.43%)
         occurrences all number
    11
    19
    11
    General disorders and administration site conditions
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    82 / 170 (48.24%)
    97 / 170 (57.06%)
    72 / 171 (42.11%)
         occurrences all number
    82
    97
    72
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    102 / 170 (60.00%)
    95 / 170 (55.88%)
    75 / 171 (43.86%)
         occurrences all number
    102
    95
    75
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    124 / 170 (72.94%)
    131 / 170 (77.06%)
    118 / 171 (69.01%)
         occurrences all number
    124
    131
    118
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    68 / 170 (40.00%)
    83 / 170 (48.82%)
    70 / 171 (40.94%)
         occurrences all number
    68
    83
    70
    Pain (post DTPw-HBV/Hib vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    127 / 170 (74.71%)
    133 / 170 (78.24%)
    140 / 171 (81.87%)
         occurrences all number
    127
    133
    140
    Pain (post Rouvax vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    52 / 163 (31.90%)
    54 / 161 (33.54%)
    47 / 159 (29.56%)
         occurrences all number
    52
    54
    47
    Pain (post GSK257049 vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    126 / 170 (74.12%)
    116 / 170 (68.24%)
    0 / 1 (0.00%)
         occurrences all number
    126
    116
    0
    Pain (post Stamaril vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    2 / 95 (2.11%)
    7 / 94 (7.45%)
    2 / 94 (2.13%)
         occurrences all number
    2
    7
    2
    Swelling (post DTPw-HBV/Hib vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    47 / 170 (27.65%)
    68 / 170 (40.00%)
    68 / 171 (39.77%)
         occurrences all number
    47
    68
    68
    Swelling (post Rouvax vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    20 / 163 (12.27%)
    21 / 161 (13.04%)
    16 / 159 (10.06%)
         occurrences all number
    20
    21
    16
    Swelling (post GSK257049 vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    28 / 170 (16.47%)
    44 / 170 (25.88%)
    0 / 1 (0.00%)
         occurrences all number
    28
    44
    0
    Induration
         subjects affected / exposed
    26 / 170 (15.29%)
    28 / 170 (16.47%)
    29 / 171 (16.96%)
         occurrences all number
    26
    28
    29
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    16 / 170 (9.41%)
    21 / 170 (12.35%)
    19 / 171 (11.11%)
         occurrences all number
    16
    21
    19
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    21 / 170 (12.35%)
    24 / 170 (14.12%)
    24 / 171 (14.04%)
         occurrences all number
    21
    24
    24
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    21 / 170 (12.35%)
    30 / 170 (17.65%)
    24 / 171 (14.04%)
         occurrences all number
    21
    30
    24
    Rhinorrhoea
         subjects affected / exposed
    19 / 170 (11.18%)
    19 / 170 (11.18%)
    23 / 171 (13.45%)
         occurrences all number
    19
    19
    23
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    66 / 170 (38.82%)
    66 / 170 (38.82%)
    65 / 171 (38.01%)
         occurrences all number
    66
    66
    65
    Nasopharyngitis
         subjects affected / exposed
    53 / 170 (31.18%)
    62 / 170 (36.47%)
    71 / 171 (41.52%)
         occurrences all number
    53
    62
    71
    Gastroenteritis
         subjects affected / exposed
    29 / 170 (17.06%)
    25 / 170 (14.71%)
    32 / 171 (18.71%)
         occurrences all number
    29
    25
    32
    Rhinitis
         subjects affected / exposed
    16 / 170 (9.41%)
    21 / 170 (12.35%)
    21 / 171 (12.28%)
         occurrences all number
    16
    21
    21
    Pneumonia
         subjects affected / exposed
    19 / 170 (11.18%)
    11 / 170 (6.47%)
    9 / 171 (5.26%)
         occurrences all number
    19
    11
    9
    Bronchitis
         subjects affected / exposed
    17 / 170 (10.00%)
    17 / 170 (10.00%)
    21 / 171 (12.28%)
         occurrences all number
    17
    17
    21
    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: This analysis was based only on those subjects from the Total Vaccinated cohort who completed symptom sheets.
    [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: This analysis was based only on those subjects from the Total Vaccinated cohort who completed symptom sheets.
    [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: This analysis was based only on those subjects from the Total Vaccinated cohort who completed symptom sheets.
    [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: This analysis was based only on those subjects from the Total Vaccinated cohort who completed symptom sheets.
    [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: This analysis was based only on those subjects from the Total Vaccinated cohort who completed symptom sheets.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Sep 2007
    The RTS,S/AS01E candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas as part of the Expanded Program of Immunization (EPI). The RTS,S/AS01E candidate malaria vaccine consists of sequences of the circumsporozoite (CS) protein and hepatitis B surface antigen (HBsAg) with the proprietary adjuvant AS01E (proprietary liposomes, MPL® and Stimulon® QS21 immunostimulants). The vaccine also induces a strong immune response against hepatitis B. Most previous malaria vaccine studies in children have been conducted with the same antigen, but administered with an adjuvant formulation from the AS02 adjuvant system family which consists of an oil-in-water emulsion, MPL® and QS21. The following table details the various vaccine formulations that have been trialed in humans, are ongoing or are planned for human trials.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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