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    Clinical Trial Results:
    A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region.

    Summary
    EudraCT number
    		 2015-001538-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    27 Dec 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    17 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    103967
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00197028
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND number: 10514
    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
    Final
    Date of interim/final analysis
    03 Jul 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Dec 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety and reactogenicity of RTS,S/AS02D administered as 3 doses intramuscularly in the left thigh to infants at 10, 14 and 18 weeks of age, staggered with the administration of 3 doses of TETRActHib (vaccine against diphteria, tetanus, pertussis and Haemophilus influenzae type B) intramuscularly in the right thigh at 8, 12 and 16 weeks of age.
    Protection of trial subjects
    The vaccines were observed closely for at least 60 minutes, with appropriate medical treatment readily available in case of an anaphylactic reaction following the administration of vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Aug 2005
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    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
    Mozambique: 220
    Worldwide total number of subjects
    220
    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)
    220
    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
    		 220 subjects were enrolled in the study out of which 214 were vaccinated and 6 were not withdrawn from the study by removal of consent by their parents/guardians.

    Pre-assignment
    Screening details
    		 The study comprised 2 phases, a double-blind vaccination phase from Month 0 to Month 6, and a single-blind phase (Month 7 to Month 14).

    Pre-assignment period milestones
    Number of subjects started
    		 220
    Number of subjects completed
    		 214

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 6
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    ‘Double blinded (observer blinded)’ means that the vaccinees and their parent(s)/guardian(s) and those responsible for the evaluation of safety, immunogenicity and efficacy endpoints were all unaware which treatment, RTS,S/AS02D or Engerix-B, was administered to a particular subject. The only study staff aware of the vaccine assignment for RTS,S/AS02D or Engerix-B will be those responsible for the preparation and administration of vaccines; these staff will play no other role in the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RTS,S/AS02D Group
    Arm description
    		 Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
    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
    TETRAct-HIB
    Investigational medicinal product code
    Other name
    TETRActHib™
    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.

    Arm title
    		 Engerix-B Group
    Arm description
    		 Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TETRAct-HIB
    Investigational medicinal product code
    Other name
    TETRActHib™
    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®, Engerix-B
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection in the thigh.

    Number of subjects in period 1 [1]
    		RTS,S/AS02D Group Engerix-B Group
    Started
    107
    107
    Completed
    91
    86
    Not completed
    16
    21
         Consent withdrawn by subject
    8
    12
         Adverse event, non-fatal
    2
    2
         Unspecified
    3
    6
         Lost to follow-up
    1
    -
         Protocol deviation
    2
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 220 subjects were enrolled in the study out of which 214 were vaccinated and 6 were not withdrawn from the study by removal of consent by their parents/guardians.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RTS,S/AS02D Group
    Reporting group description
    		 Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.

    Reporting group title
    Engerix-B Group
    Reporting group description
    		 Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.

    Reporting group values
    		 RTS,S/AS02D Group Engerix-B Group Total
    Number of subjects
    		 107 107 214
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 8.3 ( 1.42 ) 8.3 ( 1.08 ) -
    Gender categorical
    Units: Subjects
        Female
    		 48 59 107
        Male
    		 59 48 107

    End points

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    End points reporting groups
    Reporting group title
    RTS,S/AS02D Group
    Reporting group description
    		 Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.

    Reporting group title
    Engerix-B Group
    Reporting group description
    		 Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.

    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 6.
    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/AS02D Group Engerix-B Group
    Number of subjects analysed
    107
    107
    Units: Subjects
        Subjects with any SAEs
    17
    17
    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
    Throughout the entire study period (from Month 0 to Month 14).
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    107
    107
    Units: Subjects
        Subjects with any SAEs
    35
    34
    No statistical analyses for this end point

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

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    End point title
    		 Concentrations of antibodies against hepatitis B (Anti-HB).
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection cut-off of the assay was 10 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Prior to vaccination at Month 0 (PRE) and 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104).
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    72
    70
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HB, PRE [N=72;70]
    14 (9.6 to 20.5)
    16.6 (11 to 25)
        Anti-HB, Day 104 [N=68;64]
    10081.6 (7394.9 to 13744.4)
    392.4 (297 to 518.5)
    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.
    End point description
    Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 0.5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    Prior to vaccination at Month 0 (PRE), 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104) and 3½ months post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 180).
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    76
    77
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-CS, PRE [N=76;77]
    0.4 (0.3 to 0.5)
    0.4 (0.3 to 0.4)
        Anti-CS, Day 104 [N=71;68]
    199.9 (150.9 to 264.7)
    0.3 (0.2 to 0.3)
        Anti-CS, Day 180 [N=53;61]
    58.8 (41.8 to 82.8)
    0.4 (0.3 to 0.5)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against anti-diphtheria (Anti-D).

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    End point title
    		 Concentrations of antibodies against anti-diphtheria (Anti-D).
    End point description
    Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine).
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    73
    72
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D
    1.4 (1.1 to 1.7)
    1.4 (1.2 to 1.7)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against tetanus (Anti-T).

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    End point title
    		 Concentrations of antibodies against tetanus (Anti-T).
    End point description
    Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine).
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    73
    72
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-T
    6.2 (5 to 7.7)
    5.1 (4.2 to 6.3)
    No statistical analyses for this end point

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

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    End point title
    		 Concentrations of anti-Bordetella pertussis toxin antibodies (Anti-BPT).
    End point description
    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 cut-off of the assay was 15 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine).
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    72
    70
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-BPT
    104.4 (89.1 to 122.4)
    106.8 (93.3 to 122.1)
    No statistical analyses for this end point

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

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    End point title
    		 Concentrations of anti-polyribosyl ribitol phosphate antibodies (Anti-PRP).
    End point description
    Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was 0.15 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine).
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    73
    72
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP
    22.1 (16.3 to 29.9)
    17.9 (13.5 to 23.6)
    No statistical analyses for this end point

    Secondary: Time to first malaria infection.

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    End point title
    		 Time to first malaria infection.
    End point description
    Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group.
    End point type
    Secondary
    End point timeframe
    Over the period starting 14 days after Dose 3 of RTS,S/AS02D or Engerix-B® vaccine and extending for 12 weeks thereafter (from Month 2.5 to Month 6).
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    93
    92
    Units: n/PYAR
    number (not applicable)
        Rate of first malaria infection
    1.01
    2.67
    No statistical analyses for this end point

    Secondary: Number of subjects prevalent for Plasmodium falciparum (P. falciparum).

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    End point title
    		 Number of subjects prevalent for Plasmodium falciparum (P. falciparum).
    End point description
    Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.
    End point type
    Secondary
    End point timeframe
    At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine).
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    88
    90
    Units: Subjects
        Subjects prevalent for P. falciparum parasitemia
    4
    7
    No statistical analyses for this end point

    Secondary: Plasmodium falciparum (P. falciparum) parasite density in subjects prevalent for parasitemia.

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    End point title
    		 Plasmodium falciparum (P. falciparum) parasite density in subjects prevalent for parasitemia.
    End point description
    The parasite density in subjects prevalent for P. falciparum parasitemia (subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 3 ½ months after administration of Dose 3 of RTS,S/AS02D or Engerix-B® vaccine (Month 6). Parasite density is expressed as mean, minimum and maximum density in parasite per µL.
    End point type
    Secondary
    End point timeframe
    At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine).
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    4
    7
    Units: Parasites per µL
    geometric mean (confidence interval 95%)
        P. falciparum Parasite density
    11573 (131 to 33471)
    10612 (89 to 31993)
    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.
    End point type
    Secondary
    End point timeframe
    During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine.
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    107
    107
    Units: Subjects
        Pain
    107
    107
        Swelling
    39
    47
    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.
    End point type
    Secondary
    End point timeframe
    During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine.
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    105
    106
    Units: Subjects
        Pain
    105
    105
        Swelling
    26
    23
    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, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C).
    End point type
    Secondary
    End point timeframe
    During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    107
    107
    Units: Subjects
        Dorwsiness
    64
    58
        Fever ≥ 37.5°C
    24
    25
        Irritability
    89
    88
        Loss of appetite
    58
    49
    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, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C).
    End point type
    Secondary
    End point timeframe
    During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine.
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    105
    106
    Units: Subjects
        Drowsiness
    60
    69
        Fever ≥ 37.5°C
    25
    23
        Irritability
    81
    81
        Loss of appetite
    53
    62
    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.
    End point type
    Secondary
    End point timeframe
    During the 14 day (Days 0-13) follow-up period after any vaccination with of TETRActHib™ vaccine.
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    107
    107
    Units: Subjects
        Subjects with any AE(s)
    64
    51
    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.
    End point type
    Secondary
    End point timeframe
    During the 14 day (Days 0-13) follow-up period after vaccination with any among Doses 1 and 2 of Engerix-B® or RTS,S/AS02D vaccine.
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    105
    106
    Units: Subjects
        Subjects with any AE(s)
    50
    47
    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.
    End point type
    Secondary
    End point timeframe
    During the 30 day (Days 0-29) follow-up period after vaccination with Dose 3 of Engerix-B® or RTS,S/AS02D vaccine.
    End point values
    		 RTS,S/AS02D Group Engerix-B Group
    Number of subjects analysed
    97
    97
    Units: Subjects
        Subjects with any AE(s)
    32
    39
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs: entire study period (Months 0-14); Unsolicited AEs: Days 0-13 or 0-29 periods (as specified in notes); Solicited local/general symptoms: 7 day (Days 0-6) follow-up period after any vaccination.
    Adverse event reporting additional description
    For solicited symptoms and unsolicited AEs assessed following vaccination, the number of participants at risk included those vaccinated subjects from the Total Vaccinated cohort who had the symptom sheet completed. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    RTS,S/AS02D Group
    Reporting group description
    		 Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.

    Reporting group title
    Engerix-B Group
    Reporting group description
    		 Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.

    Serious adverse events
    		 RTS,S/AS02D Group Engerix-B Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 107 (32.71%)
    34 / 107 (31.78%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    17 / 107 (15.89%)
    13 / 107 (12.15%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 107 (1.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 107 (1.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyper reactivity
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    13 / 107 (12.15%)
    18 / 107 (16.82%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 18
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Plasmodium falciparum infection
         subjects affected / exposed
    15 / 107 (14.02%)
    13 / 107 (12.15%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    4 / 107 (3.74%)
    5 / 107 (4.67%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    3 / 107 (2.80%)
    4 / 107 (3.74%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 107 (3.74%)
    3 / 107 (2.80%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    2 / 107 (1.87%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 107 (0.93%)
    2 / 107 (1.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 107 (0.93%)
    3 / 107 (2.80%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyoderma
         subjects affected / exposed
    1 / 107 (0.93%)
    2 / 107 (1.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascariasis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tinea capitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    4 / 107 (3.74%)
    3 / 107 (2.80%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Marasmus
         subjects affected / exposed
    2 / 107 (1.87%)
    2 / 107 (1.87%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 RTS,S/AS02D Group Engerix-B Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    107 / 107 (100.00%)
    107 / 107 (100.00%)
    Blood and lymphatic system disorders
    Anaemia (14-day FU after TETRAct/Hib vaccination)
    Additional description: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
         subjects affected / exposed
    11 / 107 (10.28%)
    4 / 107 (3.74%)
         occurrences all number
    11
    4
    General disorders and administration site conditions
    Pain (7-day after vaccination with TETRAct/Hib)
    Additional description: During the 7-day follow-up period after vaccination with TETRAct/Hib vaccine
    alternative assessment type: Systematic
         subjects affected / exposed
    107 / 107 (100.00%)
    107 / 107 (100.00%)
         occurrences all number
    107
    107
    Swelling (7-day after vaccination with TETRAct/Hib)
    Additional description: During the 7-day follow-up period after vaccination with TETRAct/Hib vaccine
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    39 / 105 (37.14%)
    47 / 106 (44.34%)
         occurrences all number
    39
    47
    Drowsiness (14-day FU after TETRAct/Hib vaccination)
    Additional description: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
    alternative assessment type: Systematic
         subjects affected / exposed
    64 / 107 (59.81%)
    58 / 107 (54.21%)
         occurrences all number
    64
    58
    Fever (14-day FU after TETRAct/Hib vaccination)
    Additional description: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
    alternative assessment type: Systematic
         subjects affected / exposed
    24 / 107 (22.43%)
    25 / 107 (23.36%)
         occurrences all number
    24
    25
    Irritability (14-day after vaccination with TETRAct/Hib)
    Additional description: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
    alternative assessment type: Systematic
         subjects affected / exposed
    89 / 107 (83.18%)
    88 / 107 (82.24%)
         occurrences all number
    89
    88
    Loss of appetite (14 day after vaccination with TETRAct/Hib)
    Additional description: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
    alternative assessment type: Systematic
         subjects affected / exposed
    58 / 107 (54.21%)
    49 / 107 (45.79%)
         occurrences all number
    58
    49
    Pyrexia (29-day after vaccination with Dose 3 of RTS,S/AS02D or Engerix-B)
    Additional description: During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-B® vaccine
         subjects affected / exposed [2]
    5 / 97 (5.15%)
    3 / 97 (3.09%)
         occurrences all number
    5
    3
    Pain (7-day after vaccination with RTS,S/AS02D or Engerix-B)
    Additional description: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    105 / 105 (100.00%)
    105 / 106 (99.06%)
         occurrences all number
    105
    105
    Swelling (7-day after vaccination with RTS,S/AS02D or Engerix-B)
    Additional description: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    23 / 106 (21.70%)
    26 / 105 (24.76%)
         occurrences all number
    23
    26
    Drowsiness (7-day after vaccination with RTS,S/AS02D or Engerix-B)
    Additional description: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    60 / 105 (57.14%)
    69 / 106 (65.09%)
         occurrences all number
    60
    69
    Fever (7-day after vaccination with RTS,S/AS02D or Engerix-B)
    Additional description: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    25 / 105 (23.81%)
    23 / 106 (21.70%)
         occurrences all number
    25
    23
    Irritability (7-day after vaccination with RTS,S/AS02D or Engerix-B)
    Additional description: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    81 / 105 (77.14%)
    81 / 106 (76.42%)
         occurrences all number
    81
    81
    Loss of appetite (7-day after vaccination with RTS,S/AS02D or Engerix-B)
    Additional description: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    53 / 105 (50.48%)
    62 / 106 (58.49%)
         occurrences all number
    53
    62
    Eye disorders
    Conjunctivitis (14-day after RTS,S/AS02D or Engerix-B vaccination)
    Additional description: During the 14-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
         subjects affected / exposed
    7 / 107 (6.54%)
    2 / 107 (1.87%)
         occurrences all number
    7
    2
    Gastrointestinal disorders
    Diarrhea (14-day FU after TETRAct/Hib vaccination)
    Additional description: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
         subjects affected / exposed
    17 / 107 (15.89%)
    6 / 107 (5.61%)
         occurrences all number
    17
    6
    Diarrhea (14-day after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-B)
    Additional description: During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-B® vaccine
         subjects affected / exposed [9]
    8 / 105 (7.62%)
    8 / 106 (7.55%)
         occurrences all number
    8
    8
    Diarrhea (29-day after vaccination with Dose 3 of RTS,S/AS02D or Engerix-B)
    Additional description: During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-B® vaccine
         subjects affected / exposed [10]
    6 / 97 (6.19%)
    6 / 97 (6.19%)
         occurrences all number
    6
    6
    Respiratory, thoracic and mediastinal disorders
    Cough (14-day FU after TETRAct/Hib vaccination)
    Additional description: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
         subjects affected / exposed
    13 / 107 (12.15%)
    10 / 107 (9.35%)
         occurrences all number
    13
    10
    Infections and infestations
    Upper respiratory tract infection (14 day FU after TETRAct/Hib vaccination)
    Additional description: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
         subjects affected / exposed
    26 / 107 (24.30%)
    18 / 107 (16.82%)
         occurrences all number
    26
    18
    Malaria (14 day FU after TETRAct/Hib vaccination)
    Additional description: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
         subjects affected / exposed
    14 / 107 (13.08%)
    7 / 107 (6.54%)
         occurrences all number
    14
    7
    Bronchitis (14 day FU after TETRAct/Hib vaccination)
    Additional description: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
         subjects affected / exposed
    7 / 107 (6.54%)
    5 / 107 (4.67%)
         occurrences all number
    7
    5
    Upper respiratory tract infection (14-day after Doses 1 and 2 of RTS,S/AS02Dor Engerix-B)
    Additional description: During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-B vaccine
         subjects affected / exposed [11]
    21 / 105 (20.00%)
    24 / 106 (22.64%)
         occurrences all number
    21
    24
    Upper respiratory tract infection (29-day FU after Dose 3 of RTS,S/AS02D or Engerix-B)
    Additional description: During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-B vaccine
         subjects affected / exposed [12]
    7 / 97 (7.22%)
    15 / 97 (15.46%)
         occurrences all number
    7
    15
    Malaria (30-day after vaccination with RTS,S/AS02D or Engerix-B)
    Additional description: During the 30-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
         subjects affected / exposed [13]
    0 / 97 (0.00%)
    7 / 97 (7.22%)
         occurrences all number
    0
    7
    Ear infection (14-day FU after TETRAct/Hib vaccination)
    Additional description: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
         subjects affected / exposed
    3 / 107 (2.80%)
    6 / 107 (5.61%)
         occurrences all number
    3
    6
    Malaria (14-day after Doses 1 and 2 of RTS,S/AS02D or Engerix-B)
    Additional description: During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-B® vaccine
         subjects affected / exposed [14]
    3 / 105 (2.86%)
    7 / 106 (6.60%)
         occurrences all number
    3
    7
    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: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [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: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [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: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [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: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [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: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Results are for subjects with available results for the indicated vaccinations received and/or period of safety follow-up specified.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jan 2005
    The exclusion criterion relating to weight of children at screening was updated to reflect the average birth weights of the local community. The minimum weight for children at screening in the trial was now expressed as a weight for age z-score. This corresponds to a weight of  3.9 kg for 2 month old boys and  3.6 kg for 2 month old girls. In order to help study personnel carrying out the screening visit, the suitable kg weights for 2 month old boys and girls were also cited in the exclusion criteria.
    12 Apr 2005
    The Centro de Investigação em Saude da Manhiça (CISM), GSK Biologicals and Malaria Vaccine Initiative (MVI) teams decided to remove assessments of candidate genes specific for malaria vaccination responses from this study. All references to the assessments were removed throughout the protocol. The volume of collected blood was increased from 1 mL to 2 mL for cell-mediated immunity (CMI) assessment. In order to assess the pertussis response it was necessary to account for maternally acquired immunity. Assessment of antibodies to pertussis at screening was omitted in previous versions of the protocol. This was corrected in this amendment.
    05 Jul 2005
    In order to expedite the recruitment for this trial, a second health centre was used to recruit mothers and vaccinate infants in addition to the health centre at Ilha Josina. This second health centre, Taninga, was similar to that at Ilha Josina. All facilities available at Ilha Josina were also available at Taninga and all staff was trained to the same standard. It was proposed to carry out all procedures in exactly the same manner as for those mothers and infants recruited at Ilha Josina. A detailed description of the facilities available at the Taninga Health Center was added to the protocol with this amendment. At the request of the Food and Drug Administration, a rationale for the proposed interim analysis at 1 month post final dose of vaccine was added. It was clarified that the Data Safety Monitoring Board (DSMB) may suspend the trial temporarily. However should it be necessary to stop the trial permanently, the responsibility remained with the Sponsor, GSK Biologicals. Treatment options for women who were HIV positive and the infants they give birth to were updated to be in line with the current recommendations of the Mozambican Ministry of Health.

    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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