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    Clinical Trial Results:
    A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age.

    Summary
    EudraCT number
    		 2011-002077-35
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    27 Jun 2012

    Results information
    Results version number
    		 v1
    This version publication date
    16 Feb 2016
    First version publication date
    11 Jun 2015
    Other versions
    		 v2 , v3

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    111634
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00829010
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000673-PIP01-09
    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
    02 Apr 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate and characterize the immune response to the Synflorix™ vaccine one month following a 3-dose (6, 10 and 14 weeks of age) primary vaccination course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants.
    Protection of trial subjects
    All subjects were supervised after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Only eligible subjects that had no contraindications to any components of the vaccines were vaccinated. Subjects were followed-up after each vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Feb 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    South Africa: 489
    Worldwide total number of subjects
    489
    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)
    489
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The oral poliovirus vaccine could be given at any time during the study (routinely given concurrently with Tritanrix™-HepB/Hib vaccine) but was not considered as study vaccine. Out of the 489 subjects enrolled in the study, only 484 subjects were assigned to a study group and received vaccination.

    Pre-assignment
    Screening details
    		 The study included 3 populations defined based on the human immunodeficiency virus status of the mother and the infant. Infant born from: •a HIV positive mother and HIV infected at Month 0 = HIV+/+. •a HIV positive mother and HIV exposed uninfected at screening = HIV+/-. •a HIV negative mother and HIV unexposed uninfected at Month 0 = HIV-

    Pre-assignment period milestones
    Number of subjects started
    		 489
    Number of subjects completed
    		 484

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 subjects non-assigned to a study group: 5
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HIV+/+ Group
    Arm description
    		 Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 and 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 and 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 and 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age and 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ given orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    GSK1024850A
    Other name
    10Pn-PD-DiT, 10Pn
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8).

    Investigational medicinal product name
    Tritanrix™-HepB/Hib
    Investigational medicinal product code
    Other name
    DTPW-HBV/Hib
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14).

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    HRV
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 2 vaccine doses (at 10 & 14 weeks of age, at study Months 1 and 2).

    Investigational medicinal product name
    Measles
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses at 9-10 months and 15-18 months of age.

    Arm title
    		 HIV+/- Group
    Arm description
    		 Infants born from a HIV positive mother and confirmed as HIV exposed uninfected.Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    GSK1024850A
    Other name
    10Pn-PD-DiT, 10Pn
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8).

    Investigational medicinal product name
    Tritanrix™-HepB/Hib
    Investigational medicinal product code
    Other name
    DTPW-HBV/Hib
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14).

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    HRV
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 2 vaccine doses (at 10 & 14 weeks of age, at study Months 1 and 2).

    Investigational medicinal product name
    Measles
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses at 9-10 months and 15-18 months of age.

    Arm title
    		 HIV-(3+1) Group
    Arm description
    		 Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    GSK1024850A
    Other name
    10Pn-PD-DiT, 10Pn
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8).

    Investigational medicinal product name
    Tritanrix™-HepB/Hib
    Investigational medicinal product code
    Other name
    DTPW-HBV/Hib
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14).

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    HRV
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 2 vaccine doses (at 10 & 14 weeks of age, at study Months 1 and 2).

    Investigational medicinal product name
    Measles
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses at 9-10 months and 15-18 months of age.

    Arm title
    		 HIV-(EPI) Group
    Arm description
    		 Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    GSK1024850A
    Other name
    10Pn-PD-DiT, 10Pn
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2).

    Investigational medicinal product name
    Tritanrix™-HepB/Hib
    Investigational medicinal product code
    Other name
    DTPW-HBV/Hib
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14).

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    HRV
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 2 vaccine doses (at 10 & 14 weeks of age, at study Months 1 and 2).

    Investigational medicinal product name
    Measles
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses at 9-10 months and 15-18 months of age.

    Arm title
    		 HIV-(2+1) Group
    Arm description
    		 Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    GSK1024850A
    Other name
    10Pn-PD-DiT, 10Pn
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 primary doses (at 6 & 14 weeks of age, at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8).

    Investigational medicinal product name
    Tritanrix™-HepB/Hib
    Investigational medicinal product code
    Other name
    DTPW-HBV/Hib
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14).

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    HRV
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 2 vaccine doses (at 10 & 14 weeks of age, at study Months 1 and 2).

    Investigational medicinal product name
    Measles
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses at 9-10 months and 15-18 months of age.

    Number of subjects in period 1 [1]
    		HIV+/+ Group HIV+/- Group HIV-(3+1) Group HIV-(EPI) Group HIV-(2+1) Group
    Started
    87
    97
    100
    100
    100
    Completed up to Month 9
    81
    92
    98
    94
    98
    Completed
    81
    92
    98
    94
    98
    Not completed
    6
    5
    2
    6
    2
         Consent withdrawn by subject
    -
    1
    1
    -
    2
         Adverse event, non-fatal
    6
    3
    -
    3
    -
         Migrated /moved from study area
    -
    1
    -
    3
    -
         Lost to follow-up
    -
    -
    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: 5 subjects enrolled, but not allocated to a group and did not receive a vaccine

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HIV+/+ Group
    Reporting group description
    		 Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 and 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 and 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 and 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age and 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ given orally.

    Reporting group title
    HIV+/- Group
    Reporting group description
    		 Infants born from a HIV positive mother and confirmed as HIV exposed uninfected.Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.

    Reporting group title
    HIV-(3+1) Group
    Reporting group description
    		 Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally

    Reporting group title
    HIV-(EPI) Group
    Reporting group description
    		 Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally

    Reporting group title
    HIV-(2+1) Group
    Reporting group description
    		 Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.

    Reporting group values
    		 HIV+/+ Group HIV+/- Group HIV-(3+1) Group HIV-(EPI) Group HIV-(2+1) Group Total
    Number of subjects
    		 87 97 100 100 100 484
    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)
    		 6.6 ± 0.92 6.3 ± 0.64 6.1 ± 0.41 6.1 ± 0.35 6.1 ± 0.29 -
    Gender categorical
    Units: Subjects
        Female
    		 50 46 58 50 47 251
        Male
    		 37 51 42 50 53 233

    End points

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    End points reporting groups
    Reporting group title
    HIV+/+ Group
    Reporting group description
    		 Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 and 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 and 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 and 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age and 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ given orally.

    Reporting group title
    HIV+/- Group
    Reporting group description
    		 Infants born from a HIV positive mother and confirmed as HIV exposed uninfected.Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.

    Reporting group title
    HIV-(3+1) Group
    Reporting group description
    		 Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally

    Reporting group title
    HIV-(EPI) Group
    Reporting group description
    		 Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally

    Reporting group title
    HIV-(2+1) Group
    Reporting group description
    		 Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.

    Primary: Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).

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    End point title
    		 Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). [1]
    End point description
    Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Results were not available at the time of the posting and are entered as equal to “9”
    End point type
    Primary
    End point timeframe
    1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (EPI) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group)
    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 intent of this endpoint was descriptive, no comparison of groups was performed.
    End point values
    		 HIV+/+ Group HIV+/- Group HIV-(3+1) Group HIV-(EPI) Group HIV-(2+1) Group
    Number of subjects analysed
    87
    97
    100
    100
    100
    Units: Subject
        ANTI-1
    9
    9
    9
    9
    9
    No statistical analyses for this end point

    Secondary: Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).

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    End point title
    		 Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
    End point description
    Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeter.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-primary vaccination period across doses.
    End point values
    		 HIV+/+ Group HIV+/- Group HIV-(3+1) Group HIV-(EPI) Group HIV-(2+1) Group
    Number of subjects analysed
    87
    97
    98
    98
    98
    Units: Subjects
        Any pain
    76
    90
    92
    95
    97
        Grade 3 pain
    19
    17
    28
    42
    34
        Any redness
    66
    76
    83
    83
    84
        Redness > 30 mm
    14
    10
    17
    20
    14
        Any swelling
    71
    79
    84
    91
    84
        Swelling > 30 mm
    25
    30
    41
    44
    31
    No statistical analyses for this end point

    Secondary: Number of Subjects with Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).

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    End point title
    		 Number of Subjects with Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
    End point description
    General AEs = diarrhoea, drowsiness, irritability, loss of appetite, vomiting and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. diarrhoea: ≥ 6 looser than normal stools/day. vomiting: ≥ 3 episodes of vomiting/day. Fever = > 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-primary vaccination period across doses.
    End point values
    		 HIV+/+ Group HIV+/- Group HIV-(3+1) Group HIV-(EPI) Group HIV-(2+1) Group
    Number of subjects analysed
    87
    97
    98
    98
    98
    Units: Subjects
        Any diarrhoea
    8
    5
    12
    10
    5
        Grade 3 diarrhoea
    2
    0
    3
    3
    2
        Related diarrhoea
    8
    5
    11
    9
    5
        Any drowsiness
    50
    61
    70
    70
    68
        Grade 3 drowsiness
    1
    6
    5
    7
    8
        Related drowsiness
    48
    57
    67
    66
    63
        Fever (axillary) >= 37.5°C
    40
    34
    41
    28
    28
        Fever (axillary) > 39.5°C
    0
    0
    2
    0
    0
        Related fever
    34
    29
    38
    27
    25
        Any irritability
    66
    81
    89
    89
    91
        Grade 3 irritability
    6
    10
    19
    13
    15
        Related irritability
    65
    77
    86
    83
    85
        Any loss of appetite
    37
    52
    56
    57
    62
        Grade 3 loss of appetite
    0
    1
    2
    2
    5
        Related loss of appetite
    36
    46
    53
    53
    58
        Any vomiting
    17
    19
    15
    18
    23
        Grade 3 vomiting
    3
    3
    4
    5
    2
        Related vomiting
    16
    16
    14
    13
    17
    No statistical analyses for this end point

    Secondary: Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).

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    End point title
    		 Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). [2]
    End point description
    Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeter.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
    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: Since HIV - (EPI) Group didn't receive booster vaccination, there are no results to be analyzed for that timeframe.
    End point values
    		 HIV+/+ Group HIV+/- Group HIV-(3+1) Group HIV-(2+1) Group
    Number of subjects analysed
    78
    91
    96
    96
    Units: Subjects
        Any pain
    42
    56
    62
    60
        Grade 3 pain
    2
    1
    2
    6
        Any redness
    27
    29
    39
    45
        Redness > 30 mm
    5
    1
    3
    0
        Any swelling
    30
    37
    38
    53
        Swelling > 30 mm
    5
    4
    8
    10
    No statistical analyses for this end point

    Secondary: Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).

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    End point title
    		 Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). [3]
    End point description
    Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature > 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine.
    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: Since HIV - (EPI) Group didn't receive booster vaccination, there are no results to be analyzed for that timeframe.
    End point values
    		 HIV+/+ Group HIV+/- Group HIV-(3+1) Group HIV-(2+1) Group
    Number of subjects analysed
    78
    91
    96
    96
    Units: Subjects
        Any drowsiness
    19
    26
    34
    33
        Grade 3 drowsiness
    2
    0
    1
    1
        Related drowsiness
    18
    25
    31
    32
        Fever >= 37.5°C
    9
    11
    7
    11
        Fever > 39.5°C
    0
    0
    0
    0
        Related fever
    8
    10
    7
    10
        Any irritability
    27
    33
    31
    43
        Grade 3 irritability
    4
    1
    1
    1
        Related irritability
    26
    33
    31
    42
        Any loss of appetite
    17
    23
    29
    37
        Grade 3 loss of appetite
    0
    0
    1
    2
        Related loss of appetite
    16
    23
    29
    33
    No statistical analyses for this end point

    Secondary: Number of Subjects With Unsolicited AEs.

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    End point title
    		 Number of Subjects With Unsolicited AEs.
    End point description
    An unsolicited adverse event is any adverse event (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
    Within the 31-day (Days 0-30) post-primary vaccination period.
    End point values
    		 HIV+/+ Group HIV+/- Group HIV-(3+1) Group HIV-(EPI) Group HIV-(2+1) Group
    Number of subjects analysed
    87
    97
    100
    100
    100
    Units: Subjects
        Any AE
    76
    89
    93
    90
    97
    No statistical analyses for this end point

    Secondary: Number of Subjects With Unsolicited AEs.

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    End point title
    		 Number of Subjects With Unsolicited AEs. [4]
    End point description
    An unsolicited adverse event is any adverse event (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
    Within the 31-day (Days 0-30) post Synflorix booster vaccination period.
    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: Since HIV - (EPI) Group didn't receive booster vaccination, there are no results to be analyzed for that timeframe.
    End point values
    		 HIV+/+ Group HIV+/- Group HIV-(3+1) Group HIV-(2+1) Group
    Number of subjects analysed
    80
    92
    98
    98
    Units: Subjects
        Any AEs
    38
    44
    50
    44
    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 assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
    End point type
    Secondary
    End point timeframe
    From study start at Month 0 (6 weeks of age and above) up to 1 month after Sinflorix booster vaccination (up to Month 9).
    End point values
    		 HIV+/+ Group HIV+/- Group HIV-(3+1) Group HIV-(EPI) Group HIV-(2+1) Group
    Number of subjects analysed
    87
    97
    100
    100
    100
    Units: Subjects
        Any SAEs
    27
    14
    9
    8
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs: from Month 0 up to Month 9. Unsolicited AEs: within the 31-day post-primary and post booster Synflorix vaccination period. Solicited AEs: During the 4-day period following the primary and booster Synflorix vaccination.
    Adverse event reporting additional description
    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
    17.0
    Reporting groups
    Reporting group title
    HIV+/+ Group
    Reporting group description
    		 Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.

    Reporting group title
    HIV+/- Group
    Reporting group description
    		 Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™- HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.

    Reporting group title
    HIV- (3+1) Group
    Reporting group description
    		 Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™- HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.

    Reporting group title
    HIV- (EPI) Group
    Reporting group description
    		 Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.

    Reporting group title
    HIV- (2+1) Group
    Reporting group description
    		 Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.

    Serious adverse events
    		 HIV+/+ Group HIV+/- Group HIV- (3+1) Group HIV- (EPI) Group HIV- (2+1) Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 87 (31.03%)
    14 / 97 (14.43%)
    9 / 100 (9.00%)
    8 / 100 (8.00%)
    8 / 100 (8.00%)
         number of deaths (all causes)
    1
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Herbal toxicity
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Near drowning
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Cerebral palsy
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trisomy 21
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular septal defect
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    2 / 100 (2.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Sudden infant death syndrome
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis neonatal
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Aids encephalopathy
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 97 (1.03%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    12 / 87 (13.79%)
    3 / 97 (3.09%)
    3 / 100 (3.00%)
    0 / 100 (0.00%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 3
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    7 / 87 (8.05%)
    3 / 97 (3.09%)
    1 / 100 (1.00%)
    2 / 100 (2.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 3
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    H1n1 influenza
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Measles
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 97 (2.06%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Meningitis meningococcal
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis tuberculous
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jiroveci pneumonia
         subjects affected / exposed
    4 / 87 (4.60%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 97 (1.03%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    10 / 87 (11.49%)
    1 / 97 (1.03%)
    1 / 100 (1.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 97 (2.06%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 97 (1.03%)
    2 / 100 (2.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Kwashiorkor
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Marasmus
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 HIV+/+ Group HIV+/- Group HIV- (3+1) Group HIV- (EPI) Group HIV- (2+1) Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    76 / 87 (87.36%)
    90 / 97 (92.78%)
    93 / 100 (93.00%)
    95 / 100 (95.00%)
    97 / 100 (97.00%)
    General disorders and administration site conditions
    Diarrhoea (solicited post-primary)
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    8 / 87 (9.20%)
    5 / 97 (5.15%)
    12 / 98 (12.24%)
    10 / 98 (10.20%)
    5 / 98 (5.10%)
         occurrences all number
    8
    5
    12
    10
    5
    Drowsiness (solicited post-primary)
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    50 / 87 (57.47%)
    61 / 97 (62.89%)
    70 / 98 (71.43%)
    70 / 98 (71.43%)
    68 / 98 (69.39%)
         occurrences all number
    50
    61
    70
    70
    68
    Drowsiness (solicited post-booster)
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    19 / 78 (24.36%)
    26 / 91 (28.57%)
    34 / 96 (35.42%)
    0 / 100 (0.00%)
    33 / 96 (34.38%)
         occurrences all number
    19
    26
    34
    0
    33
    Fever (post-primary)
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    40 / 87 (45.98%)
    34 / 97 (35.05%)
    41 / 98 (41.84%)
    28 / 98 (28.57%)
    28 / 98 (28.57%)
         occurrences all number
    40
    34
    41
    28
    28
    Fever (post-booster)
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    9 / 78 (11.54%)
    11 / 91 (12.09%)
    7 / 96 (7.29%)
    0 / 100 (0.00%)
    11 / 96 (11.46%)
         occurrences all number
    9
    11
    7
    0
    11
    Irritability (post-primary)
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    66 / 87 (75.86%)
    81 / 97 (83.51%)
    89 / 98 (90.82%)
    89 / 98 (90.82%)
    91 / 98 (92.86%)
         occurrences all number
    66
    81
    89
    89
    91
    Irritability (post-booster)
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    27 / 78 (34.62%)
    33 / 91 (36.26%)
    31 / 96 (32.29%)
    0 / 100 (0.00%)
    43 / 96 (44.79%)
         occurrences all number
    27
    33
    31
    0
    43
    Loss of appetite (post-primary)
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    37 / 87 (42.53%)
    52 / 97 (53.61%)
    56 / 98 (57.14%)
    57 / 98 (58.16%)
    62 / 98 (63.27%)
         occurrences all number
    37
    52
    56
    57
    62
    Loss of appetite (post-booster)
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    17 / 78 (21.79%)
    23 / 91 (25.27%)
    29 / 96 (30.21%)
    0 / 100 (0.00%)
    37 / 96 (38.54%)
         occurrences all number
    17
    23
    29
    0
    37
    Pain (post-primary)
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    76 / 87 (87.36%)
    90 / 97 (92.78%)
    92 / 98 (93.88%)
    95 / 98 (96.94%)
    97 / 98 (98.98%)
         occurrences all number
    76
    90
    92
    95
    97
    Pain (post-booster)
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    42 / 78 (53.85%)
    56 / 91 (61.54%)
    62 / 96 (64.58%)
    0 / 100 (0.00%)
    60 / 96 (62.50%)
         occurrences all number
    42
    56
    62
    0
    60
    Redness (post-primary)
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    66 / 87 (75.86%)
    76 / 97 (78.35%)
    83 / 98 (84.69%)
    83 / 98 (84.69%)
    84 / 98 (85.71%)
         occurrences all number
    66
    76
    83
    83
    84
    Redness (post-booster)
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    27 / 78 (34.62%)
    29 / 91 (31.87%)
    39 / 96 (40.63%)
    0 / 100 (0.00%)
    45 / 96 (46.88%)
         occurrences all number
    27
    29
    39
    0
    45
    Swelling (post-primary)
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    71 / 87 (81.61%)
    79 / 97 (81.44%)
    84 / 98 (85.71%)
    91 / 98 (92.86%)
    84 / 98 (85.71%)
         occurrences all number
    71
    79
    84
    91
    84
    Swelling (post-booster)
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    30 / 78 (38.46%)
    37 / 91 (40.66%)
    38 / 96 (39.58%)
    0 / 100 (0.00%)
    53 / 96 (55.21%)
         occurrences all number
    30
    37
    38
    0
    53
    Vomiting (solicited post-primary)
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    17 / 87 (19.54%)
    19 / 97 (19.59%)
    15 / 98 (15.31%)
    18 / 98 (18.37%)
    23 / 98 (23.47%)
         occurrences all number
    17
    19
    15
    18
    23
    Gastrointestinal disorders
    Diarrhoea (unsol. primary)
         subjects affected / exposed
    13 / 87 (14.94%)
    16 / 97 (16.49%)
    18 / 100 (18.00%)
    13 / 100 (13.00%)
    7 / 100 (7.00%)
         occurrences all number
    13
    16
    18
    13
    7
    Diarrhoea (unsol. post-booster)
         subjects affected / exposed [17]
    5 / 80 (6.25%)
    10 / 92 (10.87%)
    10 / 98 (10.20%)
    0 / 100 (0.00%)
    8 / 98 (8.16%)
         occurrences all number
    5
    10
    10
    0
    8
    Vomiting (unsolicited post-primary)
         subjects affected / exposed
    18 / 87 (20.69%)
    16 / 97 (16.49%)
    11 / 100 (11.00%)
    15 / 100 (15.00%)
    12 / 100 (12.00%)
         occurrences all number
    18
    16
    11
    15
    12
    Vomiting (unsolicited post-booster)
         subjects affected / exposed [18]
    1 / 80 (1.25%)
    8 / 92 (8.70%)
    7 / 98 (7.14%)
    0 / 100 (0.00%)
    5 / 98 (5.10%)
         occurrences all number
    1
    8
    7
    0
    5
    Respiratory, thoracic and mediastinal disorders
    Cough (post-primary)
         subjects affected / exposed
    38 / 87 (43.68%)
    69 / 97 (71.13%)
    67 / 100 (67.00%)
    58 / 100 (58.00%)
    66 / 100 (66.00%)
         occurrences all number
    38
    69
    67
    58
    66
    Cough (post-booster)
         subjects affected / exposed [19]
    19 / 80 (23.75%)
    21 / 92 (22.83%)
    24 / 98 (24.49%)
    0 / 100 (0.00%)
    13 / 98 (13.27%)
         occurrences all number
    19
    21
    24
    0
    13
    Nasal Obstruction (post-primary)
         subjects affected / exposed
    29 / 87 (33.33%)
    40 / 97 (41.24%)
    50 / 100 (50.00%)
    49 / 100 (49.00%)
    51 / 100 (51.00%)
         occurrences all number
    29
    40
    50
    49
    51
    Nasal Obstruction (post-booster)
         subjects affected / exposed [20]
    7 / 80 (8.75%)
    4 / 92 (4.35%)
    6 / 98 (6.12%)
    0 / 100 (0.00%)
    6 / 98 (6.12%)
         occurrences all number
    7
    4
    6
    0
    6
    Rhinorrhoea
         subjects affected / exposed [21]
    1 / 80 (1.25%)
    5 / 92 (5.43%)
    7 / 98 (7.14%)
    0 / 100 (0.00%)
    5 / 98 (5.10%)
         occurrences all number
    1
    5
    7
    0
    5
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    9 / 87 (10.34%)
    12 / 97 (12.37%)
    11 / 100 (11.00%)
    12 / 100 (12.00%)
    14 / 100 (14.00%)
         occurrences all number
    9
    12
    11
    12
    14
    Rash (post-primary)
         subjects affected / exposed
    27 / 87 (31.03%)
    24 / 97 (24.74%)
    16 / 100 (16.00%)
    28 / 100 (28.00%)
    21 / 100 (21.00%)
         occurrences all number
    27
    24
    16
    28
    21
    Rash (post-booster)
         subjects affected / exposed [22]
    4 / 80 (5.00%)
    4 / 92 (4.35%)
    3 / 98 (3.06%)
    0 / 100 (0.00%)
    5 / 98 (5.10%)
         occurrences all number
    4
    4
    3
    0
    5
    Infections and infestations
    Upper respiratory tract infection (post-primary)
         subjects affected / exposed
    4 / 87 (4.60%)
    13 / 97 (13.40%)
    13 / 100 (13.00%)
    11 / 100 (11.00%)
    12 / 100 (12.00%)
         occurrences all number
    4
    13
    13
    11
    12
    Upper respiratory tract infection (post-booster)
         subjects affected / exposed [23]
    3 / 80 (3.75%)
    4 / 92 (4.35%)
    6 / 98 (6.12%)
    0 / 100 (0.00%)
    5 / 98 (5.10%)
         occurrences all number
    3
    4
    6
    0
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed [24]
    4 / 80 (5.00%)
    6 / 92 (6.52%)
    4 / 98 (4.08%)
    0 / 100 (0.00%)
    4 / 98 (4.08%)
         occurrences all number
    4
    6
    4
    0
    4
    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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the solicited symptom included only subjects with documented data.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the solicited symptom included only subjects with documented data.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the unsolicited symptom included only subjects with documented data.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the unsolicited symptom included only subjects with documented data.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the unsolicited symptom included only subjects with documented data.
    [20] - 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: The analysis of the unsolicited symptom included only subjects with documented data.
    [21] - 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: The analysis of the unsolicited symptom included only subjects with documented data.
    [22] - 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: The analysis of the unsolicited symptom included only subjects with documented data.
    [23] - 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: The analysis of the unsolicited symptom included only subjects with documented data.
    [24] - 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: The analysis of the unsolicited symptom included only subjects with documented data.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Dec 2008
    • Introduction of Prevenar in the national recommended vaccination program of South Africa as from April 2009. • Decision to consider rotavirus vaccine as study vaccine due to its anticipated introduction into the national vaccination program during 2009. • Addition of a rationale for including HIV exposed uninfected children in the study.
    29 Jun 2009
    • Decision to test immunogenicity of the oral poliovirus vaccine (OPV) on request of local authorities. • Permission for inclusion of HIV infected infants with weight for age < 3rd percentile at Visit 1, using standard growth charts, at the discretion of the investigator.
    24 Feb 2010
    As a slow enrolment rate of HIV+/+ subjects was observed, it was decided to extend the recruitment time by approximately 6 months in Amendment 3 in order to increase the chance to reach target enrolment in the HIV+/+ study group.

    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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