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    Clinical Trial Results:
    Antibody persistence in healthy South African children after primary series and booster vaccination with an investigational (DTaP-IPV-Hep B-PRP-T) or control vaccines

    Summary
    EudraCT number
    		 2011-004450-26
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    07 Sep 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2016
    First version publication date
    20 Nov 2014
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A3L26
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01105559
    WHO universal trial number (UTN)
    		 U1111-1111-5789
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, Avenue Pont Pasteur, Lyon Cedex 07, France, F-69367
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 5843, emmanuel.feroldi@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 5843, emmanuel.feroldi@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001201-PIP01-11
    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
    21 May 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the antibody long term persistence at 3.5 and 4.5 years of age following a 3-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + oral poliovirus vaccine (OPV) + Engerix™ B vaccination at 6, 10, and 14 weeks of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + OPV at 15-18 months
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Study participants must have been enrolled in a previous study, A3L15 and completed a 3-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib+oral poliovirus vaccine (OPV)+Engerix B vaccination at 6, 10 and 14 weeks of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T or CombAct-Hib+OPV at 15 to 18 months.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    29 Apr 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    South Africa: 453
    Worldwide total number of subjects
    453
    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)
    0
    Children (2-11 years)
    453
    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
    		 Study subjects were enrolled from 29 April 2010 to 07 September 2011 in 2 clinical centers in Republic of South Africa.

    Pre-assignment
    Screening details
    		 A total of 567 subjects included in the primary and booster series of study A3L15 were invited to participate in the current study, A3L26. Four hundered and fifty five (455) subjects were enrolled at visit 1, 2 were withdrawn for protocol violation.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Subjects who previously received DTaP-IPV-Hep B-PRP-T vaccine for primary and booster series vaccinations in A3L15 study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hexaxim
    Investigational medicinal product code
    DTaP-IPV-HepB-PRP-T vaccine
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No vaccination was administered as part of this study.

    Arm title
    		 Group 2
    Arm description
    		 Subjects who previously received DTwP-Hib (CombAct-Hib) + Hep B (Engerix B) + oral poliovirus vaccines (OPV) for primary series vaccinations and CombAct-Hib + OPV as a booster vaccine in study A3L15.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    CombAct-Hib™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the anterolateral area of the right thigh, previously injected in A3L15 at primary series and booster vaccinations.

    Investigational medicinal product name
    Engerix B™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No vaccination was administered as part of this study.

    Investigational medicinal product name
    OPVERO (Oral Poliomyelitis Vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    No vaccination was administered as part of this study.

    Arm title
    		 Group 3
    Arm description
    		 Subjects who previously received DTaP-IPV-Hep B-PRP-T + Hep B at birth vaccines for primary series vaccinations and DTaP-IPV-Hep B-PRP-T as a booster in study A3L15.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hexaxim
    Investigational medicinal product code
    DTaP-IPV-HepB-PRP-T vaccine
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the anterolateral area of the right thigh, previously injected in A3L15 at primary series and booster vaccinations.

    Investigational medicinal product name
    Engerix B™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the anterolateral area of the left thigh, previously injected in A3L15 at birth

    Number of subjects in period 1
    		Group 1 Group 2 Group 3
    Started
    173
    177
    103
    Completed
    167
    167
    102
    Not completed
    6
    10
    1
         Consent withdrawn by subject
    3
    3
    1
         Lost to follow-up
    3
    7
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Subjects who previously received DTaP-IPV-Hep B-PRP-T vaccine for primary and booster series vaccinations in A3L15 study.

    Reporting group title
    Group 2
    Reporting group description
    		 Subjects who previously received DTwP-Hib (CombAct-Hib) + Hep B (Engerix B) + oral poliovirus vaccines (OPV) for primary series vaccinations and CombAct-Hib + OPV as a booster vaccine in study A3L15.

    Reporting group title
    Group 3
    Reporting group description
    		 Subjects who previously received DTaP-IPV-Hep B-PRP-T + Hep B at birth vaccines for primary series vaccinations and DTaP-IPV-Hep B-PRP-T as a booster in study A3L15.

    Reporting group values
    		 Group 1 Group 2 Group 3 Total
    Number of subjects
    		 173 177 103 453
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 173 177 103 453
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 43.4 ( 0.967 ) 43.4 ( 0.994 ) 43.2 ( 0.994 ) -
    Gender categorical
    Units: Subjects
        Female
    		 92 82 49 223
        Male
    		 81 95 54 230

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Subjects who previously received DTaP-IPV-Hep B-PRP-T vaccine for primary and booster series vaccinations in A3L15 study.

    Reporting group title
    Group 2
    Reporting group description
    		 Subjects who previously received DTwP-Hib (CombAct-Hib) + Hep B (Engerix B) + oral poliovirus vaccines (OPV) for primary series vaccinations and CombAct-Hib + OPV as a booster vaccine in study A3L15.

    Reporting group title
    Group 3
    Reporting group description
    		 Subjects who previously received DTaP-IPV-Hep B-PRP-T + Hep B at birth vaccines for primary series vaccinations and DTaP-IPV-Hep B-PRP-T as a booster in study A3L15.

    Primary: Percentage of Subjects Achieving the Predefined Antibody Thresholds for Vaccine Antigens at Age 3.5 Years old and at Age 4.5 Years old Following Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T Combined Vaccine or CombAct-Hib™ and OPV and Engerix™ B

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    End point title
    		 Percentage of Subjects Achieving the Predefined Antibody Thresholds for Vaccine Antigens at Age 3.5 Years old and at Age 4.5 Years old Following Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T Combined Vaccine or CombAct-Hib™ and OPV and Engerix™ B [1]
    End point description
    Anti-diphtheria antibodies were measured by a toxin neutralization test. Anti-tetanus, anti-pertussis toxin (PT), and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology. Anti-Haemophilus influenzae type b capsular polyribosyl ribitol phosphate (PRP) antibody concentrations were measured using a Farr-type radioimmunoassay (RIA). Lower limit of quantitation (LLOQ) values for anti-PT and anti-FHA was 2 EU/mL. Subjects vaccinated in Study A3L15 were assessed at Year 1 (Visit 01) defined as the first time point of follow-up at about 2 years (Month 24 to Month 27) post-booster vaccination, when subjects were aged 3.5 years and also at Year 2 (Visit 02) defined as the second time point of follow-up at about 3 years (Month 36 to Month 39) post-booster vaccination, when subjects were aged 4.5 years.
    End point type
    Primary
    End point timeframe
    Month 24 to Month 27 and Month 36 to Month 39 post-booster dose
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3
    Number of subjects analysed
    173
    177
    103
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria; Year 1-V01 (≥0.01 IU/mL)
    98.8
    91.5
    98.1
        Anti-Diphtheria; Year 1-V01 (≥0.1 IU/mL)
    81.3
    47.2
    68.9
        Anti-Diphtheria; Year 1-V01 (≥1.0 IU/mL)
    32.7
    2.8
    24.3
        Anti-Diphtheria; Year 2-V02 (≥0.01 IU/mL)
    98.2
    87.5
    97
        Anti-Diphtheria; Year 2-V02 (≥0.1 IU/mL)
    75.3
    33.1
    64.4
        Anti-Diphtheria; Year 2-V02 (≥1.0 IU/mL)
    18.7
    0
    24.8
        Anti-Tetanus; Year 1-V01 (≥0.01 IU/mL)
    100
    100
    100
        Anti-Tetanus; Year 1-V01 (≥0.1 IU/mL)
    94.7
    93.7
    94.1
        Anti-Tetanus; Year 1-V01 (≥1.0 IU/mL)
    38.2
    8.6
    36.6
        Anti-Tetanus; Year 2-V02 (≥0.01 IU/mL)
    100
    100
    100
        Anti-Tetanus; Year 2-V02 (≥0.1 IU/mL)
    89.5
    84.5
    82.8
        Anti-Tetanus; Year 2-V02 (≥1.0 IU/mL)
    26.5
    3.2
    20.2
        Anti-PT; Year 1-V01 (≥LLOQ)
    95.9
    86.7
    90
        Anti-PT; Year 1-V01 (≥2xLLOQ)
    87.1
    80.9
    77
        Anti-PT; Year 1-V01 (≥4xLLOQ)
    60.6
    55.5
    52
        Anti-PT; Year 2-V02 (≥LLOQ)
    83.6
    80.1
    78.5
        Anti-PT; Year 2-V02 (≥2xLLOQ)
    74
    69.5
    54.8
        Anti-PT; Year 2-V02 (≥4xLLOQ)
    42.5
    44.4
    23.7
        Anti-FHA; Year 1-V01 (≥LLOQ)
    100
    99.4
    100
        Anti-FHA; Year 1-V01 (≥2xLLOQ)
    99.4
    92.4
    100
        Anti-FHA; Year 1-V01 (≥4xLLOQ)
    97.7
    70.8
    95
        Anti-FHA; Year 2-V02 (≥LLOQ)
    100
    94.8
    100
        Anti-FHA; Year 2-V02 (≥2xLLOQ)
    100
    86.3
    97
        Anti-FHA; Year 2-V02 (≥4xLLOQ)
    93.8
    62.1
    89
        Anti-Hep B; Year 1-V01 (≥10 mIU/mL)
    76.3
    72.7
    96.1
        Anti-Hep B; Year 1-V01 (≥100 mIU/mL)
    49.1
    22.2
    86.4
        Anti-Hep B; Year 2-V02 (≥10 mIU/mL)
    73.3
    68.5
    96.1
        Anti-Hep B; Year 2-V02 (≥100 mIU/mL)
    40
    17
    84.3
        Anti-PRP; Year 1-V01 (≥0.15 µg/mL)
    98.3
    99.4
    99
        Anti-PRP; Year 1-V01 (≥1.0 µg/mL)
    87.9
    87
    89.3
        Anti-PRP; Year 2-V02 (≥0.15 µg/mL)
    98.8
    98.8
    100
        Anti-PRP; Year 2-V02 (≥1.0 µg/mL)
    84.7
    84.1
    78.4
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Antibodies Against Vaccine Antigens at Age 3.5 Years and 4.5 Years old Following Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T Combined Vaccine or CombAct-Hib™ and OPV and Engerix™ B in a Previous Study

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Against Vaccine Antigens at Age 3.5 Years and 4.5 Years old Following Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T Combined Vaccine or CombAct-Hib™ and OPV and Engerix™ B in a Previous Study [2]
    End point description
    Anti-diphtheria antibodies were measured by a toxin neutralization test. Anti-tetanus, anti-pertussis toxin (PT), and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology. Anti-Haemophilus influenzae type b capsular polyribosyl ribitol phosphate (PRP) antibody concentrations were measured using a Farr-type radioimmunoassay (RIA). Subjects vaccinated in Study A3L15 were assessed at Year 1 (Visit 01) defined as the first time point of follow-up at about 2 years (Month 24 to Month 27) post-booster vaccination, when subjects were aged 3.5 years and also at Year 2 (Visit 02) defined as the second time point of follow-up at about 3 years (Month 36 to Month 39) post-booster vaccination, when subjects were aged 4.5 years.
    End point type
    Primary
    End point timeframe
    Month 24 to Month 27 and Month 36 to Month 39 post-booster dose
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3
    Number of subjects analysed
    173
    177
    103
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Year 1-V01
    0.437 (0.344 to 0.556)
    0.086 (0.069 to 0.107)
    0.244 (0.175 to 0.342)
        Anti-Diphtheria; Year 2-V02
    0.272 (0.214 to 0.345)
    0.048 (0.038 to 0.061)
    0.222 (0.155 to 0.319)
        Anti-Tetanus; Year 1-V01
    0.703 (0.594 to 0.831)
    0.371 (0.329 to 0.418)
    0.588 (0.473 to 0.731)
        Anti-Tetanus; Year 2-V02
    0.489 (0.411 to 0.583)
    0.246 (0.213 to 0.283)
    0.343 (0.273 to 0.43)
        Anti-PT; Year 1-V01
    10.8 (9.17 to 12.7)
    8.82 (7.34 to 10.6)
    7.09 (5.73 to 8.76)
        Anti-PT; Year 2-V02
    6.68 (5.43 to 8.21)
    6.09 (5.02 to 7.39)
    4.27 (3.38 to 5.41)
        Anti-FHA; Year 1-V01
    68.4 (58 to 80.7)
    17 (14 to 20.7)
    60.4 (46.8 to 78)
        Anti-FHA; Year 2-V02
    46.3 (39.3 to 54.5)
    14.1 (11.2 to 17.7)
    33.3 (26.8 to 41.4)
        Anti-Hep B; Year 1-V01
    76.3 (54.1 to 108)
    30 (23.8 to 37.7)
    1175 (756 to 1827)
        Anti-Hep B; Year 2-V02
    54 (38.8 to 75.3)
    22.6 (17.7 to 28.9)
    882 (567 to 1373)
        Anti-PRP; Year 1-V01
    4.96 (3.98 to 6.18)
    4.33 (3.59 to 5.22)
    4.44 (3.31 to 5.95)
        Anti-PRP; Year 2-V02
    4.14 (3.34 to 5.13)
    3.48 (2.83 to 4.3)
    3.34 (2.56 to 4.37)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Anti-diphtheria Immunogenicity Response at Primary Series Vaccinations, at Age 3.5 Years and Age 4.5 Years old after Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T Combined Vaccine or CombAct-Hib™ and OPV and Engerix™ B

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    End point title
    		 Percentage of Subjects with Anti-diphtheria Immunogenicity Response at Primary Series Vaccinations, at Age 3.5 Years and Age 4.5 Years old after Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T Combined Vaccine or CombAct-Hib™ and OPV and Engerix™ B [3]
    End point description
    Anti-diphtheria (D) antibodies were measured by a toxin neutralization test. Subjects vaccinated in Study A3L15 were assessed at Year 1 (Visit 01) defined as the first time point of follow-up at about 2 years (Month [M] 24 to M27) post-booster vaccination, when subjects were aged 3.5 years and also at Year 2 (Visit 02) defined as the second time point of follow-up at about 3 years (M36 to M39) post-booster vaccination, when subjects were aged 4.5 years.
    End point type
    Primary
    End point timeframe
    Month 24 to Month 27 and Month 36 to Month 39 post-booster dose
    Notes
    [3] - 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3
    Number of subjects analysed
    173
    177
    103
    Units: Percentage of subjects
    number (not applicable)
        Anti-D; A3L15 Primary (D126; ≥0.01 IU/mL)
    96.9
    95.3
    95.1
        Anti-D; A3L15 Primary (D126; ≥0.1 IU/mL)
    39.8
    14.6
    36.3
        Anti-D; A3L15 Primary (D126; ≥1.0 IU/mL)
    1.2
    0
    2
        Anti-D; A3L15 Pre-Booster (D540; ≥0.01 IU/mL)
    92.2
    85.1
    84.5
        Anti-D; A3L15 Pre-Booster (D540; ≥0.1 IU/mL)
    29.9
    10.9
    35.9
        Anti-D; A3L15 Pre-Booster (D540; ≥1.0 IU/mL)
    1.2
    0
    0
        Anti-D; A3L15 Post-Booster (D570; ≥0.01 IU/mL)
    100
    100
    100
        Anti-D; A3L15 Post-Booster (D570; ≥0.1 IU/mL)
    100
    98.3
    100
        Anti-D; A3L15 Post-Booster (D570; ≥1.0 IU/mL)
    97.6
    92
    92.8
        Anti-D; A3L26 Year 1-V01 (M24 to M27; ≥0.01 IU/mL)
    98.8
    91.5
    98.1
        Anti-D; A3L26 Year 1-V01 (M24 to M27; ≥0.1 IU/mL)
    81.3
    47.2
    68.9
        Anti-D; A3L26 Year 1-V01 (M24 to M27; ≥1.0 IU/mL)
    32.7
    2.8
    24.3
        Anti-D; A3L26 Year 2-V02 (M36 to M39; ≥0.01 IU/mL)
    98.2
    87.5
    97
        Anti-D; A3L26 Year 2-V02 (M36 to M39; ≥0.1 IU/mL)
    75.3
    33.1
    64.4
        Anti-D; A3L26 Year 2-V02 (M36 to M39; ≥1.0 IU/mL)
    18.7
    0
    24.8
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Anti-tetanus Immunogenicity Response at Primary Series Vaccinations, at Age 3.5 Years and at Age 4.5 Years old after Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T combined vaccine or CombAct-Hib™ and OPV and Engerix™ B.

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    End point title
    		 Percentage of Subjects with Anti-tetanus Immunogenicity Response at Primary Series Vaccinations, at Age 3.5 Years and at Age 4.5 Years old after Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T combined vaccine or CombAct-Hib™ and OPV and Engerix™ B. [4]
    End point description
    Anti-tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Subjects vaccinated in Study A3L15 were assessed at Year 1 (Visit 01) defined as the first time point of follow-up at about 2 years (Month [M] 24 to M27) post-booster vaccination, when subjects were aged 3.5 years and also at Year 2 (Visit 02) defined as the second time point of follow-up at about 3 years (M36 to M39) post-booster vaccination, when subjects were aged 4.5 years.
    End point type
    Primary
    End point timeframe
    Month 24 to Month 27 and Month 36 to Month 39 post-booster dose
    Notes
    [4] - 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3
    Number of subjects analysed
    173
    177
    103
    Units: Percentage of subjects
    number (not applicable)
        Anti-T; A3L15 Primary (D126; ≥0.01 IU/mL)
    100
    100
    100
        Anti-T; A3L15 Primary (D126; ≥0.1 IU/mL)
    100
    100
    100
        Anti-T; A3L15 Primary (D126; ≥1.0 IU/mL)
    74.3
    81.6
    64.7
        Anti-T; A3L15 Pre-Booster (D540; ≥0.01 IU/mL)
    100
    100
    100
        Anti-T; A3L15 Pre-Booster (D540; ≥0.1 IU/mL)
    74.8
    90.6
    65
        Anti-T; A3L15 Pre-Booster (D540; ≥1.0 IU/mL)
    6.7
    8.8
    3.9
        Anti-T; A3L15 Post-Booster (D570; ≥0.01 IU/mL)
    100
    100
    100
        Anti-T; A3L15 Post-Booster (D570; ≥0.1 IU/mL)
    100
    100
    100
        Anti-T; A3L15 Post-Booster (D570; ≥1.0 IU/mL)
    97.6
    99.4
    97
        Anti-T; A3L26 Year 1-V01 (M24 to M27; ≥0.01 IU/mL)
    100
    100
    100
        Anti-T; A3L26 Year 1-V01 (M24 to M27; ≥0.1 IU/mL)
    94.7
    93.7
    94.1
        Anti-T; A3L26 Year 1-V01 (M24 to M27; ≥1.0 IU/mL)
    38.2
    8.6
    36.6
        Anti-T; A3L26 Year 2-V02 (M36 to M39; ≥0.01 IU/mL)
    100
    100
    100
        Anti-T; A3L26 Year 2-V02 (M36 to M39; ≥0.1 IU/mL)
    89.5
    84.5
    82.8
        Anti-T; A3L26 Year 2-V02 (M36 to M39; ≥1.0 IU/mL)
    26.5
    3.2
    20.2
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Anti-pertussis Immunogenicity Response at Primary Series Vaccinations at Age 3.5 Years and at Age 4.5 Years old after Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T Combined Vaccine or CombAct-Hib™ and OPV and Engerix™ B

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    End point title
    		 Percentage of Subjects with Anti-pertussis Immunogenicity Response at Primary Series Vaccinations at Age 3.5 Years and at Age 4.5 Years old after Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T Combined Vaccine or CombAct-Hib™ and OPV and Engerix™ B [5]
    End point description
    Anti-pertussis toxin (PT) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantitation (LLOQ) values for anti-PT was 2 EU/mL. Subjects vaccinated in Study A3L15 were assessed at Year 1 (Visit 01) defined as the first time point of follow-up at about 2 years (Month [M] 24 to M27) post-booster vaccination, when subjects were aged 3.5 years and also at Year 2 (Visit 02) defined as the second time point of follow-up at about 3 years (M36 to M39) post-booster vaccination, when subjects were aged 4.5 years.
    End point type
    Primary
    End point timeframe
    Month 24 to Month 27 and Month 36 to Month 39 post-booster dose
    Notes
    [5] - 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3
    Number of subjects analysed
    173
    177
    103
    Units: Percentage of subjects
    number (not applicable)
        Anti-PT; A3L15 Primary (D126; ≥LLOQ)
    100
    99.2
    100
        Anti-PT; A3L15 Primary (D126; ≥2xLLOQ)
    100
    98.4
    100
        Anti-PT; A3L15 Primary (D126; ≥4xLLOQ)
    100
    94.5
    100
        Anti-PT; A3L15 Pre-Booster (D540; ≥LLOQ)
    98.6
    83.9
    97.8
        Anti-PT; A3L15 Pre-Booster (D540; ≥2xLLOQ)
    91.6
    72.6
    88.9
        Anti-PT; A3L15 Pre-Booster (D540; ≥4xLLOQ)
    63.6
    64.5
    60
        Anti-PT; A3L15 Post-Booster (D570; ≥LLOQ)
    100
    93.9
    100
        Anti-PT; A3L15 Post-Booster (D570; ≥2xLLOQ)
    100
    93.3
    100
        Anti-PT; A3L15 Post-Booster (D570; ≥4xLLOQ)
    100
    92.7
    100
        Anti-PT; A3L26 Year 1-V01 (M24 to M27; ≥LLOQ)
    95.9
    86.7
    90
        Anti-PT; A3L26 Year 1-V01 (M24 to M27; ≥2xLLOQ)
    87.1
    80.9
    77
        Anti-PT; A3L26 Year 1-V01 (M24 to M27; ≥4xLLOQ)
    60.6
    55.5
    52
        Anti-PT; A3L26 Year 2-V02 (M36 to M39; ≥LLOQ)
    83.6
    80.1
    78.5
        Anti-PT; A3L26 Year 2-V02 (M36 to M39; ≥2xLLOQ)
    74
    69.5
    54.8
        Anti-PT; A3L26 Year 2-V02 (M36 to M39; ≥4xLLOQ)
    42.5
    44.4
    23.7
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Anti-Filamentous Hemagglutinin Response at Primary Series Vaccinations, at Age 3.5 Years and 4.5 Years old after Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T Combined Vaccine or CombAct-Hib™ and OPV and Engerix™ B.

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    End point title
    		 Percentage of Subjects with Anti-Filamentous Hemagglutinin Response at Primary Series Vaccinations, at Age 3.5 Years and 4.5 Years old after Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T Combined Vaccine or CombAct-Hib™ and OPV and Engerix™ B. [6]
    End point description
    Anti- filamentous hemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantitation (LLOQ) values for anti-FHA was 2 EU/mL. Subjects vaccinated in Study A3L15 were assessed at Year 1 (Visit 01) defined as the first time point of follow-up at about 2 years (Month [M] 24 to M27) post-booster vaccination, when subjects were aged 3.5 years and also at Year 2 (Visit 02) defined as the second time point of follow-up at about 3 years (M36 to M39) post-booster vaccination, when subjects were aged 4.5 years.
    End point type
    Primary
    End point timeframe
    Month 24 to Month 27 and Month 36 to Month 39 post-booster dose
    Notes
    [6] - 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3
    Number of subjects analysed
    173
    177
    103
    Units: Percentage of subjects
    number (not applicable)
        Anti-FHA; A3L15 Primary (D126; ≥LLOQ)
    100
    100
    100
        Anti-FHA; A3L15 Primary (D126; ≥2xLLOQ)
    100
    100
    100
        Anti-FHA; A3L15 Primary (D126; ≥4xLLOQ)
    100
    97.6
    100
        Anti-FHA; A3L15 Pre-Booster (D540; ≥LLOQ)
    100
    87.9
    100
        Anti-FHA; A3L15 Pre-Booster (D540; ≥2xLLOQ)
    97.4
    65.9
    100
        Anti-FHA; A3L15 Pre-Booster (D540; ≥4xLLOQ)
    89.4
    34.1
    86.5
        Anti-FHA; A3L15 Post-Booster (D570; ≥LLOQ)
    100
    100
    100
        Anti-FHA; A3L15 Post-Booster (D570; ≥2xLLOQ)
    100
    100
    100
        Anti-FHA; A3L15 Post-Booster (D570; ≥4xLLOQ)
    100
    100
    100
        Anti-FHA; A3L26 Year 1-V01 (M24 to M27; ≥LLOQ)
    100
    99.4
    100
        Anti-FHA; A3L26 Year 1-V01 (M24 to M27; ≥2xLLOQ)
    99.4
    92.4
    100
        Anti-FHA; A3L26 Year 1-V01 (M24 to M27; ≥4xLLOQ)
    97.7
    70.8
    95
        Anti-FHA; A3L26 Year 2-V02 (M36 to M39; ≥LLOQ)
    100
    94.8
    100
        Anti-FHA; A3L26 Year 2-V02 (M36 to M39; ≥2xLLOQ)
    100
    86.3
    97
        Anti-FHA; A3L26 Year 2-V02 (M36 to M39; ≥4xLLOQ)
    93.8
    62.1
    89
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Anti-hepatitis B Immunogenicity Response at Primary Series Vaccination at Age 3.5 Years and at Age 4.5 Years old after Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T Combined Vaccine or CombAct-Hib™ and OPV and Engerix™B

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    End point title
    		 Percentage of Subjects with Anti-hepatitis B Immunogenicity Response at Primary Series Vaccination at Age 3.5 Years and at Age 4.5 Years old after Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T Combined Vaccine or CombAct-Hib™ and OPV and Engerix™B [7]
    End point description
    Anti-hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology. Subjects vaccinated in Study A3L15 were assessed at Year 1 (Visit 01) defined as the first time point of follow-up at about 2 years (Month [M] 24 to M27) post-booster vaccination, when subjects were aged 3.5 years and also at Year 2 (Visit 02) defined as the second time point of follow-up at about 3 years (M36 to M39) post-booster vaccination, when subjects were aged 4.5 years.
    End point type
    Primary
    End point timeframe
    Month 24 to Month 27 and Month 36 to Month 39 post-booster dose
    Notes
    [7] - 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3
    Number of subjects analysed
    173
    177
    103
    Units: Percentage of subjects
    number (not applicable)
        Anti-Hep B; A3L15 Primary (D126; ≥10 mIU/mL)
    95.2
    95.5
    98.8
        Anti-Hep B; A3L15 Primary (D126; ≥100 mIU/mL)
    75.2
    63.1
    96.3
        Anti-Hep B; A3L15 Pre-Booster (D540; ≥10 mIU/mL)
    76.9
    92
    93
        Anti-Hep B; A3L15 Pre-Booster (D540; ≥100 mIU/mL)
    36.7
    55.1
    75
        Anti-Hep B; A3L15 Post-Booster (D570; ≥10 mIU/mL)
    98.2
    90
    100
        Anti-Hep B; A3L15 Post-Booster (D570; ≥100 mIU/mL)
    93.4
    54.1
    99
        Anti-Hep B; A3L26 Y1-V01 (M24 to M27; ≥10 mIU/mL)
    76.3
    72.7
    96.1
        Anti-Hep B; A3L26 Y1-V01 (M24 to M27; ≥100 mIU/mL)
    49.1
    22.2
    86.4
        Anti-Hep B; A3L26 Y2-V02 (M36 to M39; ≥10 mIU/mL)
    73.3
    68.5
    96.1
        Anti-Hep B; A3L26 Y2-V02 (M36 to M39; ≥100 mIU/mL)
    40
    17
    84.3
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Anti- PRP Immunogenicity Response at Primary Series Vaccination, at Age 3.5 Years and at Age 4.5 Years old after Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T combined vaccine or CombAct-Hib™ and OPV and Engerix™ B.

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    End point title
    		 Percentage of Subjects with Anti- PRP Immunogenicity Response at Primary Series Vaccination, at Age 3.5 Years and at Age 4.5 Years old after Primary Series Vaccinations with DTaP-IPV-Hep B-PRP-T combined vaccine or CombAct-Hib™ and OPV and Engerix™ B. [8]
    End point description
    Anti-Haemophilus influenzae type b capsular polyribosyl ribitol phosphate (PRP) antibody concentrations were measured using a Farr-type radioimmunoassay (RIA). Subjects vaccinated in Study A3L15 were assessed at Year 1 (Visit 01) defined as the first time point of follow-up at about 2 years (Month [M] 24 to M27) post-booster vaccination, when subjects were aged 3.5 years and also at Year 2 (Visit 02) defined as the second time point of follow-up at about 3 years (M36 to M39) post-booster vaccination, when subjects were aged 4.5 years.
    End point type
    Primary
    End point timeframe
    Month 24 to Month 27 and Month 36 to Month 39 post-booster dose
    Notes
    [8] - 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3
    Number of subjects analysed
    173
    177
    103
    Units: Percentage of subjects
    number (not applicable)
        Anti-PRP; A3L15 Primary (D126; ≥0.15 µg/mL)
    95.9
    100
    98
        Anti-PRP; A3L15 Primary (D126; ≥1.0 µg/mL)
    79.1
    93.2
    74.5
        Anti-PRP; A3L15 Pre-Booster (D540; ≥0.15 µg/mL)
    82.7
    92.6
    74.8
        Anti-PRP; A3L15 Pre-Booster (D540; ≥1.0 µg/mL)
    45.1
    54.9
    35
        Anti-PRP; A3L15 Post-Booster (D570; ≥0.15 µg/mL)
    100
    100
    100
        Anti-PRP; A3L15 Post-Booster (D570; ≥1.0 µg/mL)
    98.8
    98.9
    100
        Anti-PRP; A3L26 Y1-V01 (M24 to M27; ≥0.15 µg/ml)
    98.3
    99.4
    99
        Anti-PRP; A3L26 Y1-V01 (M24 to M27; ≥1.0 µg/ml)
    87.9
    87
    89.3
        Anti-PRP; A3L26 Y2-V02 (M36 to M39; ≥0.15 µg/ml)
    98.8
    98.8
    100
        Anti-PRP; A3L26 Y2-V02 (M36 to M39; ≥1.0 µg/ml)
    84.7
    84.1
    78.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    No safety data were collected in A3L26.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Safety data were not solicited or collected for this study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2010
    Deletion of analysis of antibody titers of poliovirus from all sections of the protocol and updated reason for excluding the analysis of antibody titers of poliovirus.

    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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