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    Clinical Trial Results:
    Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP~T Vaccine Administered at 2- 4-6 Months of Age in Healthy Mexican Infants

    Summary
    EudraCT number
    		 2011-004455-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Jun 2008

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A3L11
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00404651
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon cedex, France, F-69367
    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?
    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
    24 Mar 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the equivalence of three batches of DTaP-IPV-Hep B-PRP-T vaccine second Drug Product Generation in terms of seroprotection rates for D, T, Hep B, PRP, and polio and seroconversion rates for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA), 1 month after a three-dose primary series (at 2, 4, and 6 months of age).
    Protection of trial subjects
    Subjects in the study received three injections of a single dose of the study vaccine DTaP-IPV-HB-PRP~T or the comparator DTaP-HBV-IPV vaccine supplied in a prefilled 0.5 mL syringe that was administered by qualified study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After each vaccination, subjects were also kept under observation for 30 minutes to ensure their safety. Appropriate equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Not Applicable
    Evidence for comparator
    		 A fourth treatment group (Infanrix hexa - DTaP-HB-IPV/Hib) was added in order to provide an estimate of the immunogenicity and safety profile of a reference licensed vaccine.
    Actual start date of recruitment
    14 Nov 2006
    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
    Mexico: 1189
    Worldwide total number of subjects
    1189
    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)
    1189
    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 14 November 2006 to 13 July 2007 in 6 clinical centers in Mexico.

    Pre-assignment
    Screening details
    		 A total of 1189 participants who met all the inclusion but none of the exclusion criteria were enrolled and vaccinated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    The Investigator (blind observer or assessor) and the subjects' parents did not know the vaccine administered. The assessor was in charge of safety assessment, held in a separate room to one in which the vaccines were prepared. A nurse/vaccinator was in charge of the preparation and administration of the vaccine(s) only, in another room away from the assessor. A scratch off emergency decoding procedure described in the study protocol was followed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DTaP-IPV-HB-PRP~T Batch 1
    Arm description
    		 Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
    Arm type
    		 Experimental

    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, intramuscular, one dose each at 2, 4, and 6 months of age.

    Arm title
    		 DTaP-IPV-HB-PRP~T Batch 2
    Arm description
    		 Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 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, intramuscular. One dose each at 2, 4, and 6 months of age.

    Arm title
    		 DTaP-IPV-HB-PRP~T Batch 3
    Arm description
    		 Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 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
    .5 mL, intramuscular. One dose each at 2, 4, and 6 months of age.

    Arm title
    		 Infanrix hexa™
    Arm description
    		 Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (3 component acellular), recombinant hepatitis B (Hep B) and poliomyelitis (IPV) vaccine adsorbed, plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein (Infanrix hexa™), a dose each at 2, 4, and 6 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix hexa™
    Investigational medicinal product code
    DTaP-HBV-IPV vaccine
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular. One dose each at 2, 4, and 6 months of age.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The Investigator served as blind observer or assessor in this study design.
    Number of subjects in period 1
    		DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix hexa™
    Started
    340
    343
    339
    167
    Completed
    301
    315
    294
    146
    Not completed
    39
    28
    45
    21
         Consent withdrawn by subject
    14
    12
    16
    6
         Adverse event, non-fatal
    -
    -
    2
    -
         Lost to follow-up
    15
    11
    13
    10
         Protocol deviation
    10
    5
    14
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTaP-IPV-HB-PRP~T Batch 1
    Reporting group description
    		 Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.

    Reporting group title
    DTaP-IPV-HB-PRP~T Batch 2
    Reporting group description
    		 Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.

    Reporting group title
    DTaP-IPV-HB-PRP~T Batch 3
    Reporting group description
    		 Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.

    Reporting group title
    Infanrix hexa™
    Reporting group description
    		 Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (3 component acellular), recombinant hepatitis B (Hep B) and poliomyelitis (IPV) vaccine adsorbed, plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein (Infanrix hexa™), a dose each at 2, 4, and 6 months of age.

    Reporting group values
    		 DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix hexa™ Total
    Number of subjects
    		 340 343 339 167 1189
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 340 343 339 167 1189
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 2 ± 0.2 2 ± 0.197 2.01 ± 0.193 1.98 ± 0.189 -
    Gender categorical
    Units: Subjects
        Female
    		 160 163 167 82 572
        Male
    		 180 180 172 85 617

    End points

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    End points reporting groups
    Reporting group title
    DTaP-IPV-HB-PRP~T Batch 1
    Reporting group description
    		 Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.

    Reporting group title
    DTaP-IPV-HB-PRP~T Batch 2
    Reporting group description
    		 Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.

    Reporting group title
    DTaP-IPV-HB-PRP~T Batch 3
    Reporting group description
    		 Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.

    Reporting group title
    Infanrix hexa™
    Reporting group description
    		 Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (3 component acellular), recombinant hepatitis B (Hep B) and poliomyelitis (IPV) vaccine adsorbed, plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein (Infanrix hexa™), a dose each at 2, 4, and 6 months of age.

    Primary: Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine

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    End point title
    		 Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine [1]
    End point description
    Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.
    End point type
    Primary
    End point timeframe
    Day 150 (one 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: This outcome presented and compared the values among the groups.
    End point values
    		 DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix hexa™
    Number of subjects analysed
    231
    231
    228
    117
    Units: Participants
        Anti-Hep B
    226
    231
    221
    119
        Anti-PRP
    229
    232
    226
    118
        Anti-Diphtheria
    220
    228
    222
    118
        Anti-Tetanus
    231
    236
    227
    119
    No statistical analyses for this end point

    Primary: Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.

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    End point title
    		 Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. [2]
    End point description
    Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.
    End point type
    Primary
    End point timeframe
    Day 150 (one month post-dose 3)
    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: This outcome presented and compared the values among the groups.
    End point values
    		 DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix hexa™
    Number of subjects analysed
    231
    236
    228
    119
    Units: Participants
        Anti-Pertussis
    223
    226
    218
    113
        Anti-FHA
    225
    229
    216
    111
    No statistical analyses for this end point

    Primary: Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV- Hep B-PRP~T or Infanrix Hexa™ Vaccine

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    End point title
    		 Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV- Hep B-PRP~T or Infanrix Hexa™ Vaccine [3]
    End point description
    Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).
    End point type
    Primary
    End point timeframe
    Day 150 (one month post-dose 3)
    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: This outcome presented and compared the values among the groups.
    End point values
    		 DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix hexa™
    Number of subjects analysed
    231
    236
    228
    119
    Units: Participants
        Anti-Polio 1
    230
    236
    225
    119
        Anti-Polio 2
    230
    236
    226
    118
        Anti-Polio 3
    229
    235
    226
    117
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine

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    End point title
    		 Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
    End point description
    Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).
    End point type
    Secondary
    End point timeframe
    Day 150 (one month post-dose 3)
    End point values
    		 DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix hexa™
    Number of subjects analysed
    231
    236
    228
    119
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Hep B
    935 (755 to 1158)
    1566 (1288 to 1905)
    1009 (814 to 1252)
    1576 (1283 to 1934)
        Anti-PRP
    11.9 (9.77 to 14.5)
    13.1 (10.7 to 16)
    11.5 (9.26 to 14.3)
    6.68 (5.1 to 8.74)
        Anti-Diphtheria
    0.176 (0.143 to 0.217)
    0.246 (0.194 to 0.311)
    0.173 (0.139 to 0.214)
    0.173 (0.132 to 0.226)
        Anti-Tetanus
    1.9 (1.67 to 2.15)
    1.86 (1.64 to 2.1)
    1.77 (1.57 to 2.01)
    2.2 (1.93 to 2.52)
        Anti-Polio 1
    860 (725 to 1021)
    945 (809 to 1102)
    843 (712 to 999)
    1370 (1082 to 1736)
        Anti-Polio 2
    1689 (1429 to 1996)
    1665 (1416 to 1957)
    1612 (1374 to 1892)
    2337 (1878 to 2909)
        Anti-Polio 3
    1198 (1015 to 1413)
    1170 (995 to 1377)
    962 (809 to 1143)
    2186 (1752 to 2727)
        Anti-Pertusiss toxoid
    242 (226 to 260)
    238 (220 to 258)
    241 (222 to 262)
    228 (205 to 254)
        Anti-FHA
    243 (228 to 259)
    256 (237 to 277)
    220 (202 to 239)
    182 (165 to 200)
    No statistical analyses for this end point

    Secondary: Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB- PRP~T Vaccine or Infanrix Hexa™ Vaccine

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    End point title
    		 Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB- PRP~T Vaccine or Infanrix Hexa™ Vaccine
    End point description
    Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-each vaccination) up to 7 days post-each dose
    End point values
    		 DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix hexa™
    Number of subjects analysed
    340
    343
    339
    167
    Units: Participants
        Solicited Injection site Pain post-dose 1
    220
    237
    225
    95
        Solicited Injection site Pain post-dose 2
    191
    220
    199
    88
        Solicited Injection site Pain post-dose 3
    188
    209
    198
    87
        Solicited Injection site Erythema post-dose 1
    92
    97
    97
    41
        Solicited Injection site Erythema post-dose 2
    94
    101
    96
    33
        Solicited Injection site Erythema post-dose 3
    95
    94
    101
    43
        Solicited Injection site Swelling post-dose 1
    67
    86
    80
    35
        Solicited Injection site Swelling post-dose 2
    74
    70
    60
    26
        Solicited Injection site Swelling post-dose 3
    66
    65
    72
    22
        Solicited Pyrexia post-dose 1
    63
    77
    82
    17
        Solicited Pyrexia Post-dose 2
    75
    84
    85
    32
        Solicited Pyrexia Post-dose 3
    69
    85
    70
    28
        Solicited Vomiting Post-dose 1
    68
    63
    56
    27
        Solicited Vomiting post-dose 2
    37
    46
    34
    18
        Solicited Vomiting post-dose 3
    51
    46
    47
    20
        Solicited Crying post-dose 1
    160
    156
    148
    62
        Solicited Crying post-dose 2
    133
    145
    134
    59
        Solicited Crying post-dose 3
    110
    118
    122
    40
        Solicited Somnolence post-dose 1
    93
    110
    102
    45
        Solicited Somnolence post-dose 2
    69
    78
    65
    24
        Solicited Somnolence post-dose 3
    56
    57
    54
    20
        Solicited Anorexia post-dose 1
    62
    75
    70
    27
        Solicited Anorexia post-dose 2
    56
    64
    65
    25
        Solicited Anorexia post-dose 3
    61
    58
    65
    29
        Solicited Irritability post-dose 1
    188
    198
    193
    83
        Solicited Irritability post-dose 2
    158
    192
    174
    72
        Solicited Irritability post-dose 3
    158
    167
    165
    69
    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 Day 0 after the first vaccination and up to 6 months after the third infant dose
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    DTaP-IPV-HB-PRP~T Batch 1
    Reporting group description
    		 Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.

    Reporting group title
    DTaP-IPV-Hep B-PRP-T Batch 2
    Reporting group description
    		 Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with one dose each at 2, 4, and 6 months of age.

    Reporting group title
    DTaP-IPV-Hep B-PRP-T Batch 3
    Reporting group description
    		 Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with one dose each at 2, 4, and 6 months of age.

    Reporting group title
    Infanrix hexa™
    Reporting group description
    		 Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.

    Serious adverse events
    		 DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-Hep B-PRP-T Batch 2 DTaP-IPV-Hep B-PRP-T Batch 3 Infanrix hexa™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 337 (1.48%)
    5 / 345 (1.45%)
    12 / 340 (3.53%)
    6 / 167 (3.59%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Head Injury
         subjects affected / exposed
    0 / 337 (0.00%)
    1 / 345 (0.29%)
    0 / 340 (0.00%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple Fractures
         subjects affected / exposed
    0 / 337 (0.00%)
    1 / 345 (0.29%)
    0 / 340 (0.00%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Heart Disease Congenital
         subjects affected / exposed
    0 / 337 (0.00%)
    1 / 345 (0.29%)
    0 / 340 (0.00%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile Convulsion
         subjects affected / exposed
    1 / 337 (0.30%)
    0 / 345 (0.00%)
    1 / 340 (0.29%)
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infantile Spasms
         subjects affected / exposed
    0 / 337 (0.00%)
    0 / 345 (0.00%)
    1 / 340 (0.29%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial Seizures
         subjects affected / exposed
    0 / 337 (0.00%)
    0 / 345 (0.00%)
    0 / 340 (0.00%)
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intussusception
         subjects affected / exposed
    0 / 337 (0.00%)
    0 / 345 (0.00%)
    1 / 340 (0.29%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asphyxia
         subjects affected / exposed
    0 / 337 (0.00%)
    0 / 345 (0.00%)
    1 / 340 (0.29%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 337 (0.30%)
    0 / 345 (0.00%)
    0 / 340 (0.00%)
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 337 (0.00%)
    0 / 345 (0.00%)
    1 / 340 (0.29%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear Infection
         subjects affected / exposed
    0 / 337 (0.00%)
    0 / 345 (0.00%)
    1 / 340 (0.29%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 337 (0.59%)
    2 / 345 (0.58%)
    5 / 340 (1.47%)
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 337 (0.30%)
    0 / 345 (0.00%)
    1 / 340 (0.29%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Food Intolerance
         subjects affected / exposed
    1 / 337 (0.30%)
    0 / 345 (0.00%)
    0 / 340 (0.00%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-Hep B-PRP-T Batch 2 DTaP-IPV-Hep B-PRP-T Batch 3 Infanrix hexa™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    220 / 337 (65.28%)
    237 / 345 (68.70%)
    225 / 340 (66.18%)
    95 / 167 (56.89%)
    Nervous system disorders
    Solicited Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    93 / 323 (28.79%)
    110 / 336 (32.74%)
    102 / 329 (31.00%)
    45 / 156 (28.85%)
         occurrences all number
    93
    110
    102
    45
    General disorders and administration site conditions
    Solicited injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    95 / 302 (31.46%)
    101 / 319 (31.66%)
    101 / 306 (33.01%)
    43 / 149 (28.86%)
         occurrences all number
    95
    101
    101
    43
    Solicited injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    220 / 323 (68.11%)
    237 / 336 (70.54%)
    225 / 329 (68.39%)
    95 / 155 (61.29%)
         occurrences all number
    220
    237
    225
    95
    Solicited injetion site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    74 / 310 (23.87%)
    86 / 336 (25.60%)
    80 / 329 (24.32%)
    35 / 156 (22.44%)
         occurrences all number
    74
    86
    80
    35
    Solicited Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    188 / 323 (58.20%)
    198 / 336 (58.93%)
    193 / 329 (58.66%)
    83 / 156 (53.21%)
         occurrences all number
    188
    198
    193
    83
    Solicited Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    75 / 310 (24.19%)
    85 / 317 (26.81%)
    85 / 315 (26.98%)
    32 / 153 (20.92%)
         occurrences all number
    75
    85
    85
    32
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    68 / 323 (21.05%)
    63 / 336 (18.75%)
    56 / 329 (17.02%)
    27 / 156 (17.31%)
         occurrences all number
    68
    63
    56
    27
    Psychiatric disorders
    Solicited Crying
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    160 / 323 (49.54%)
    156 / 336 (46.43%)
    148 / 329 (44.98%)
    62 / 156 (39.74%)
         occurrences all number
    160
    156
    148
    62
    Metabolism and nutrition disorders
    Solicited Anorexia
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    62 / 323 (19.20%)
    75 / 336 (22.32%)
    70 / 329 (21.28%)
    29 / 149 (19.46%)
         occurrences all number
    62
    75
    70
    29
    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 number presented are those exposed subjects that retured the safety diary card during the solicited events 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: The number presented are those exposed subjects that retured the safety diary card during the solicited events 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: The number presented are those exposed subjects that retured the safety diary card during the solicited events 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: The number presented are those exposed subjects that retured the safety diary card during the solicited events 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: The number presented are those exposed subjects that retured the safety diary card during the solicited events 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: The number presented are those exposed subjects that retured the safety diary card during the solicited events 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: The number presented are those exposed subjects that retured the safety diary card during the solicited events 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: The number presented are those exposed subjects that retured the safety diary card during the solicited events 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: The number presented are those exposed subjects that retured the safety diary card during the solicited events period.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Oct 2006
    Amendment 1 of Protocol (Version 7.0) was produced to align the study with prevailing immunization of pregnant women practice in Mexico and the addition of a secondary objective on non-inferiority of anti-Dihtheria seroprotection. The collection of maternal vaccination history was also included.
    15 Nov 2007
    Amendment 4 of Protocol (Version 10.0) was produced to extend the time intervals between vaccinations and between vaccination and blood samples to be used for the primary series in order to maintain the defined attrition rate for the study.

    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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