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    Clinical Trial Results:
    Immunogenicity Study of a DTaP IPV Hep B PRP T Combined Vaccine in Comparison to CombAct Hib™ Concomitantly Administered with Engerix B™ Pediatric and OPV at 6, 10, and 14 Weeks of Age in South African Infants.

    Summary
    EudraCT number
    		 2011-004433-14
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Aug 2009

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

    Trial information

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    Trial identification
    Sponsor protocol code
    A3L15
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00362336
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur, SA
    Sponsor organisation address
    1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 58 43 , emmanuel.feroldi@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 58 43 , 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?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Dec 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Aug 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP-T combined vaccine does not induce a lower immune response than CombAct-Hib™ with Engerix B™ Pediatric and OPV in terms of seroprotection rates to D, T, polio, Hep B, and polyribosyl ribitol phosphate (PRP), 1 month after a three-dose primary series (at 6, 10, and 14 weeks) with no Hep B vaccination at birth.
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Aug 2006
    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: 622
    Worldwide total number of subjects
    622
    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)
    622
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study participants were enrolled from 28 August 2006 to 11 February 2007 in 2 clinical centers in South Africa.

    Pre-assignment
    Screening details
    		 A total of 622 of the 715 recruited participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

    Period 1
    Period 1 title
    Overall (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
    		 DTaP-IPV-Hep B-PRP~T Group
    Arm description
    		 Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
    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
    0.5 mL at age 6, 10, and 14 weeks, and a booster dose at age 15 to 18 months

    Arm title
    		 CombAct-Hib™ + Engerix B™ + OPV Group
    Arm description
    		 Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    CombAct-Hib™
    Investigational medicinal product code
    Tetract-Hib
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, 3 priming doses of CombAct Hib™ + Engerix B™ Oral Poliovirus Vaccine (OPV) at 6, 10, and 14 weeks, and a booster dose of CombAct Hib™ + OPV at 15 to 18 months.

    Investigational medicinal product name
    OPVERO
    Investigational medicinal product code
    Oral Poliomyelitis Vaccine
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    0.1 mL, 3 priming doses at age 6, 10, and 14 weeks, and a booster dose at age 15 to 18 months

    Investigational medicinal product name
    Engerix B™
    Investigational medicinal product code
    Hepatitis B Surface antigen
    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. Three priming doses at age 6, 10, and 14 weeks

    Arm title
    		 DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Arm description
    		 Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hexaxim
    Investigational medicinal product code
    DTaP-IPV-Hep B-PRP-T
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age.

    Investigational medicinal product name
    Engerix B™
    Investigational medicinal product code
    Hepatitis B Surface antigen
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, at birth.

    Number of subjects in period 1
    		DTaP-IPV-Hep B-PRP~T Group CombAct-Hib™ + Engerix B™ + OPV Group DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Started
    243
    242
    137
    Completed
    233
    235
    134
    Not completed
    10
    7
    3
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    3
    3
    1
         Adverse event, non-fatal
    1
    -
    -
         Lost to follow-up
    6
    4
    -
         Protocol deviation
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP~T Group
    Reporting group description
    		 Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.

    Reporting group title
    CombAct-Hib™ + Engerix B™ + OPV Group
    Reporting group description
    		 Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.

    Reporting group title
    DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Reporting group description
    		 Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.

    Reporting group values
    		 DTaP-IPV-Hep B-PRP~T Group CombAct-Hib™ + Engerix B™ + OPV Group DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group Total
    Number of subjects
    		 243 242 137 622
    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)
    		 243 242 137 622
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    		 1.04 ± 0.729 1.07 ± 0.762 1.11 ± 0.773 -
    Gender categorical
    Units: Subjects
        Female
    		 131 118 68 317
        Male
    		 112 124 69 305

    End points

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    End points reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP~T Group
    Reporting group description
    		 Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.

    Reporting group title
    CombAct-Hib™ + Engerix B™ + OPV Group
    Reporting group description
    		 Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.

    Reporting group title
    DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Reporting group description
    		 Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.

    Primary: Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)

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    End point title
    		 Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) [1]
    End point description
    Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil).
    End point type
    Primary
    End point timeframe
    1 month post-Dose 3
    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 vaccine groups from the primary series for the follow-up booster vaccination in this study.
    End point values
    		 DTaP-IPV-Hep B-PRP~T Group CombAct-Hib™ + Engerix B™ + OPV Group DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Number of subjects analysed
    222
    212
    123
    Units: Participants
        Anti-Hep B
    176
    185
    97
        Anti-PRP
    209
    212
    119
        Anti-Diphtheria
    201
    198
    116
        Anti-Tetanus
    213
    210
    122
        Anti-Polio Type 1
    186
    174
    103
        Anti-Polio Type 2
    193
    192
    111
        Anti-Polio Type 3
    182
    176
    98
    No statistical analyses for this end point

    Secondary: Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)

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    End point title
    		 Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
    End point description
    Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. Seroprotection was defined as a titer ≥ 100 mIU/mL for anti-Hep B; ≥ 1 µg/mL for anti-PRP; ≥ 0.1 IU/mL (Level 1) and ≥ 1.0 IU/mL (Level 2) for anti-Diphtheria and anti-Tetanus. Seroconversion for anti-PT and anti-FHA was a ≥ 4-fold increase from baseline.
    End point type
    Secondary
    End point timeframe
    1 month post-Dose 3
    End point values
    		 DTaP-IPV-Hep B-PRP~T Group CombAct-Hib™ + Engerix B™ + OPV Group DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Number of subjects analysed
    220
    212
    123
    Units: Participants
        Anti-Hep B
    145
    127
    95
        Anti-PRP
    174
    196
    97
        Anti-Diphtheria Level 1
    82
    28
    48
        Anti-Diphtheria Level 2
    3
    0
    4
        Anti-Tetanus Level 1
    213
    210
    122
        Anti-Tetanus Level 2
    158
    173
    83
        Anti-Pertussis Toxoid
    161
    114
    98
        anti-Filamentous hemagglutinin
    149
    75
    81
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
    End point description
    Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio-immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.
    End point type
    Secondary
    End point timeframe
    Day 42 before Dose 1 and 1 month post-Dose 3
    End point values
    		 DTaP-IPV-Hep B-PRP~T Group CombAct-Hib™ + Engerix B™ + OPV Group DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Number of subjects analysed
    220
    212
    123
    Units: titre
    geometric mean (confidence interval 95%)
        Anti-Hep B Post-dose 3
    330 (259 to 420)
    148 (120 to 181)
    1913 (1457 to 2513)
        Anti-PRP Post-dose 3
    3.31 (2.69 to 4.08)
    5.18 (4.47 to 6)
    3.83 (2.92 to 5.02)
        Anti-Diphtheria Post-dose 3
    0.074 (0.062 to 0.088)
    0.04 (0.035 to 0.046)
    0.074 (0.059 to 0.094)
        Anti-Tetanus Post-dose 3
    1.51 (1.37 to 1.65)
    1.88 (1.7 to 2.07)
    1.33 (1.17 to 1.51)
        Anti-Polio Type 1 Post-dose 3
    579 (478 to 702)
    198 (153 to 256)
    557 (410 to 756)
        Anti-Polio Type 2 Post-dose 3
    620 (512 to 750)
    446 (374 to 533)
    371 (281 to 489)
        Anti-Polio Type 3 Post-dose 3
    975 (812 to 1170)
    228 (185 to 280)
    811 (645 to 1020)
        Anti-PT Pre-Dose 1
    7.77 (6.56 to 9.21)
    7.66 (6.23 to 9.42)
    6.62 (5.29 to 8.3)
        Anti-PT Post-dose 3
    332 (304 to 362)
    191 (147 to 249)
    288 (256 to 323)
        Anti-Filamentous hemagglutinin Pre-dose 1
    9.27 (8.02 to 10.7)
    8.02 (6.82 to 9.42)
    8.3 (6.8 to 10.1)
        Anti-Filamentous hemagglutinin Post-dose 3
    207 (190 to 226)
    37.4 (33.4 to 41.9)
    188 (166 to 212)
    No statistical analyses for this end point

    Secondary: Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV

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    End point title
    		 Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV
    End point description
    Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-poliovirus types 1, 2, and 3 by neutralization assay. Persistence and response were defined as a titer ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-Diphtheria and anti-Tetanus, ≥ 8 (1/dil) for anti-Poliovirus, and ≥ 4 EU/mL for anti-PT and anti-FHA.
    End point type
    Secondary
    End point timeframe
    Day 540 pre-booster and Day 570 post-booster
    End point values
    		 DTaP-IPV-Hep B-PRP~T Group CombAct-Hib™ + Engerix B™ + OPV Group DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Number of subjects analysed
    204
    202
    116
    Units: Participants
        Anti-Hep B pre-booster
    157
    183
    107
        Anti-Hep B post-booster
    194
    0
    113
        Anti-PRP pre-booster
    166
    185
    88
        Anti-PRP post-booster
    203
    201
    115
        Anti-Diphtheria pre-booster
    184
    173
    98
        Anti-Diphtheria post-booster
    195
    200
    111
        Anti-Tetanus pre-booster
    189
    195
    116
        Anti-Tetanus post-booster
    200
    199
    114
        Anti-Polio Type 1 pre-booster
    185
    178
    108
        Anti-Polio Type 1 post-booster
    189
    186
    108
        Anti-Polio Type 2 pre-booster
    187
    190
    109
        Anti-Polio Type 2 post-booster
    191
    190
    107
        Anti-Polio Type 3 pre-booster
    186
    185
    110
        Anti-Polio Type 3 post-booster
    188
    185
    108
        Anti-PT pre-booster
    151
    100
    95
        Anti-PT post-booster
    187
    173
    109
        Anti-PT post/pre-booster ratio
    145
    111
    93
        Anti-FHA pre-booster
    170
    99
    102
        Anti-FHA post-booster
    184
    190
    105
        Anti-FHA post/pre-booster ratio
    145
    138
    89
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV
    End point description
    Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.
    End point type
    Secondary
    End point timeframe
    Day 540 pre-booster and Day 570, post-booster
    End point values
    		 DTaP-IPV-Hep B-PRP~T Group CombAct-Hib™ + Engerix B™ + OPV Group DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Number of subjects analysed
    204
    202
    116
    Units: titre
    geometric mean (confidence interval 95%)
        Anti-Hep B pre-booster
    51.3 (40 to 65.8)
    103 (83.3 to 127)
    228 (172 to 303)
        Anti-Hep B post-booster
    4630 (3402 to 6302)
    86.2 (69.2 to 107)
    44893 (33652 to 59890)
        Anti-Hep B post/pre-booster ratio
    88.7 (74 to 106)
    0 (0 to 0)
    191 (157 to 231)
        Anti-PRP pre-booster
    0.757 (0.585 to 0.98)
    1.19 (0.948 to 1.48)
    0.631 (0.448 to 0.889)
        Anti-PRP post-booster
    68.5 (55.7 to 84.2)
    52.2 (43.9 to 62.2)
    63.1 (47.6 to 83.8)
        Anti-PRP post/pre-booster ratio
    89 (71.4 to 111)
    43.6 (34.5 to 55)
    97.4 (71.7 to 132)
        Anti-Diphtheria pre-booster
    0.06 (0.05 to 0.073)
    0.027 (0.023 to 0.032)
    0.045 (0.033 to 0.059)
        Anti-Diphtheria post-booster
    9.37 (8.05 to 10.9)
    3.33 (2.92 to 3.8)
    7 (5.61 to 8.72)
        Anti-Diphtheria post/pre-booster ratio
    158 (137 to 182)
    123 (108 to 140)
    153 (125 to 189)
        Anti-Tetanus pre-booster
    0.219 (0.189 to 0.254)
    0.311 (0.276 to 0.352)
    0.173 (0.143 to 0.208)
        Anti-Tetanus post-booster
    10 (8.65 to 11.7)
    8.23 (7.49 to 9.04)
    8.13 (6.68 to 9.89)
        Anti-Tetanus post/pre-booster ratio
    45.5 (40 to 51.8)
    26.5 (23.5 to 29.9)
    47.4 (39.8 to 56.3)
        Anti-Polio Type 1 pre-booster
    127 (104 to 155)
    151 (118 to 192)
    142 (107 to 190)
        Anti-Polio Type 1 post-booster
    7298 (6202 to 8588)
    329 (260 to 417)
    5346 (4309 to 6633)
        Anti-Polio Type 1 post/pre-booster ratio
    59 (47 to 74)
    2.27 (1.8 to 2.85)
    38.4 (27.4 to 53.7)
        Anti-Polio Type 2 pre-booster
    210 (170 to 260)
    246 (204 to 296)
    191 (144 to 255)
        Anti-Polio Type 2 post-booster
    6637 (5745 to 7668)
    863 (665 to 1118)
    4190 (3460 to 5074)
        Anti-Polio Type 2 post/pre-booster ratio
    32.4 (24.9 to 42.3)
    3.82 (2.9 to 5.04)
    23.2 (16.2 to 33.3)
        Anti-Polio Type 3 pre-booster
    161 (130 to 199)
    114 (96.4 to 135)
    127 (97.9 to 165)
        Anti-Polio Type 3 post-booster
    6411 (5525 to 7493)
    315 (245 to 404)
    5144 (4156 to 6367)
        Anti-Polio Type 3 post/pre-booster ratio
    40.5 (31 to 53)
    2.92 (2.26 to 3.77)
    41.2 (29.3 to 57.9)
        Anti-Pertussis toxoid pre-booster
    11.6 (9.88 to 13.6)
    10.4 (8.03 to 13.6)
    12 (9.62 to 14.9)
        Anti-Pertussis toxoid post-booster
    288 (260 to 318)
    110 (88.7 to 137)
    235 (206 to 268)
        Anti-Pertussis toxoid post/pre-booster ratio
    26.1 (21.8 to 31.1)
    10.6 (8.56 to 13.1)
    20.5 (16.5 to 25.4)
        Anti-FHA pre-booster
    30.5 (25.4 to 36.7)
    5.43 (4.52 to 6.53)
    25.1 (19.7 to 31.9)
        Anti-FHA post-booster
    570 (514 to 630)
    211 (193 to 231)
    472 (419 to 533)
        Anti-FHA post/pre-booster ratio
    18.9 (15.8 to 22.6)
    40.8 (34.5 to 48.1)
    20.3 (16.5 to 24.9)
    No statistical analyses for this end point

    Secondary: Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)

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    End point title
    		 Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
    End point description
    Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain - crying when injected limb is moved or the movement reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature ≥ 39.0ºC; Vomiting - ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability - inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post each dose
    End point values
    		 DTaP-IPV-Hep B-PRP~T Group CombAct-Hib™ + Engerix B™ + OPV Group DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Number of subjects analysed
    243
    242
    137
    Units: Participants
        Pain post-dose 1
    166
    177
    95
        Pain post-dose 2
    171
    171
    97
        Pain post-dose 3
    143
    162
    83
        Grade 3 Pain post-any dose
    17
    24
    7
        Erythema post-dose 1
    112
    133
    69
        Erythema post-dose 2
    116
    114
    59
        Erythema post-dose 3
    103
    106
    56
        Grade 3 Erythema post-any dose
    9
    15
    2
        Swelling post-dose 1
    87
    102
    48
        Swelling post-dose 2
    88
    109
    43
        Swelling post-dose 3
    74
    89
    39
        Grade 3 Swelling post-any dose
    9
    10
    4
        Pyrexia post-dose 1
    50
    38
    27
        Pyrexia post-dose 2
    43
    35
    18
        Pyrexia post-dose 3
    48
    34
    21
        Grade 3 Pyrexia post-any dose
    4
    1
    0
        Vomiting post-dose 1
    59
    59
    30
        Vomiting post-dose 2
    52
    56
    35
        Vomiting post-dose 3
    56
    49
    31
        Grade 3 Vomiting post-any dose
    14
    7
    6
        Crying post-dose 1
    138
    154
    91
        Crying post-dose 2
    131
    135
    74
        Crying post-dose 3
    106
    116
    66
        Grade 3 Crying post-any dose
    15
    20
    9
        Somnolence post-dose 1
    100
    103
    57
        Somnolence post-dose 2
    79
    90
    47
        Somnolence post-dose 3
    72
    69
    43
        Grade 3 Somnolence post-any dose
    9
    9
    8
        Anorexia post-dose 1
    62
    87
    42
        Anorexia post-dose 2
    66
    68
    39
        Anorexia post-dose 3
    64
    76
    39
        Grade 3 Anorexia post-any dose
    9
    13
    5
        Irritability post-dose 1
    128
    137
    77
        Irritability post-dose 2
    114
    118
    66
        Irritability post-dose 3
    94
    99
    53
        Grade 3 Irritability post-any dose
    18
    16
    5
    No statistical analyses for this end point

    Secondary: Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)

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    End point title
    		 Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
    End point description
    Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, crying when injected limb is moved or the movement reduced; Erythema and Swelling, ≥ 5 cm; Fever, temperature ≥ 39.0ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability, inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 7 post-booster vaccination
    End point values
    		 DTaP-IPV-Hep B-PRP~T Group CombAct-Hib™ + Engerix B™ + OPV Group DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Number of subjects analysed
    218
    219
    130
    Units: Participants
        Injection site Pain
    138
    149
    84
        Grade 3 injection site Pain
    5
    4
    1
        Injection site Erythema
    102
    104
    54
        Grade 3 injection site Erythema
    3
    2
    2
        Injection site Swelling
    75
    98
    48
        Grade 3 injection site Swelling
    2
    11
    5
        Extensive Swelling of vaccinated limb
    0
    0
    0
        Grade 3 extensive Swelling of vaccinated limb
    0
    0
    0
        Pyrexia
    61
    50
    37
        Grade 3 Pyrexia
    1
    2
    2
        Vomiting
    22
    28
    14
        Grade 3 Vomiting
    0
    2
    0
        Crying
    106
    115
    58
        Grade 3 Crying
    3
    0
    2
        Somnolence
    85
    80
    43
        Grade 3 Somnolence
    3
    1
    1
        Anorexia
    88
    99
    55
        Grade 3 Anorexia
    8
    4
    4
        Irritability
    98
    103
    52
        Grade 3 Irritability
    2
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP~T Group
    Reporting group description
    		 Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.

    Reporting group title
    CombAct-Hib™ + Engerix B™ + OPV Group
    Reporting group description
    		 Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.

    Reporting group title
    DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Reporting group description
    		 Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.

    Serious adverse events
    		 DTaP-IPV-Hep B-PRP~T Group CombAct-Hib™ + Engerix B™ + OPV Group DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 243 (2.88%)
    6 / 242 (2.48%)
    5 / 137 (3.65%)
         number of deaths (all causes)
    2
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Congenital, familial and genetic disorders
    Heart disease congenital
         subjects affected / exposed
    1 / 243 (0.41%)
    1 / 242 (0.41%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular septal defect
         subjects affected / exposed
    0 / 243 (0.00%)
    0 / 242 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Pulmonary Valve Stenosis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 242 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 242 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Impairment
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 242 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 242 (0.41%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 242 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 242 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    2 / 243 (0.82%)
    2 / 242 (0.83%)
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysentery
         subjects affected / exposed
    0 / 243 (0.00%)
    0 / 242 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 243 (0.82%)
    1 / 242 (0.41%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    0 / 243 (0.00%)
    0 / 242 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 243 (0.00%)
    0 / 242 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 242 (0.41%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 242 (0.41%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 242 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Failure to thrive
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 242 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DTaP-IPV-Hep B-PRP~T Group CombAct-Hib™ + Engerix B™ + OPV Group DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    202 / 243 (83.13%)
    210 / 242 (86.78%)
    119 / 137 (86.86%)
    Nervous system disorders
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    143 / 236 (60.59%)
    143 / 238 (60.08%)
    78 / 135 (57.78%)
         occurrences all number
    143
    143
    78
    General disorders and administration site conditions
    Injection-site bruising
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    6 / 237 (2.53%)
    9 / 238 (3.78%)
    9 / 136 (6.62%)
         occurrences all number
    6
    9
    9
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    160 / 236 (67.80%)
    173 / 238 (72.69%)
    91 / 135 (67.41%)
         occurrences all number
    160
    173
    91
    Injection site pain
         subjects affected / exposed [4]
    202 / 237 (85.23%)
    210 / 238 (88.24%)
    119 / 136 (87.50%)
         occurrences all number
    202
    210
    119
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    130 / 236 (55.08%)
    150 / 238 (63.03%)
    65 / 136 (47.79%)
         occurrences all number
    130
    150
    65
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    157 / 236 (66.53%)
    165 / 238 (69.33%)
    94 / 135 (69.63%)
         occurrences all number
    157
    165
    94
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    105 / 236 (44.49%)
    79 / 238 (33.19%)
    45 / 136 (33.09%)
         occurrences all number
    105
    79
    45
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    106 / 243 (43.62%)
    100 / 242 (41.32%)
    54 / 135 (40.00%)
         occurrences all number
    106
    100
    54
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed [9]
    13 / 237 (5.49%)
    4 / 238 (1.68%)
    4 / 136 (2.94%)
         occurrences all number
    13
    4
    4
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    180 / 236 (76.27%)
    186 / 238 (78.15%)
    112 / 135 (82.96%)
         occurrences all number
    180
    186
    112
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed [11]
    11 / 237 (4.64%)
    13 / 238 (5.46%)
    4 / 136 (2.94%)
         occurrences all number
    11
    13
    4
    Metabolism and nutrition disorders
    Anorexia
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    110 / 236 (46.61%)
    133 / 238 (55.88%)
    67 / 136 (49.26%)
         occurrences all number
    110
    133
    67
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jun 2007
    The protocol amendment includes an extension of the age group for MMR and varicella vaccinations and timing of the booster dose to 15 to 18 months; revision of the Informed consent form, addition of inclusion criteria for booster phase, addition solicited adverse event and clarification immunogenicity and points and analyses.
    29 Nov 2007
    The amendment include an increase in the sample size, revision of timing of blood sample storage and clotting in line with new sample preparation procedures, and removal of ‘height’ from Visit 01 demographic characteristics.
    20 Dec 2007
    The amendment includes the addition of a secondary endpoint, revision of assay procedure, and inclusion of five protocol violation criteria.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/21289531
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