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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 Latin American Infants Concomitantly with Prevenar™ and Rotarix™

    Summary
    EudraCT number
    		 2011-004449-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Sep 2011

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

    Trial information

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    Trial identification
    Sponsor protocol code
    A3L24
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01177722
    WHO universal trial number (UTN)
    		 U1111-1111-5801
    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 4 37 37 5843, emmanuel.feroldi@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 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
    12 Apr 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To demonstrate the equivalence of immunogenicity on 3 lots of DTaP-IPV-Hep B-PRP-T vaccine (final bulk product [FBP]) one month after a three-dose primary series (2, 4 and 6 months) when co-administered with Prevenar™ and Rotarix™ , in terms of immunoresponses evaluated by: - Geometric Means of Titers (GMTs) for Hep B. - Seroprotection rates for D, T, Hep B, PRP, and polio and seroresponse rates for anti-PT and anti-FHA. - To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa™ vaccine in terms of seroprotection or seroresponse rates to all antigens, one month after a three-dose primary series when co-administered with Prevenar™ and Rotarix™.
    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
    		 All subjects participating in the study were to have received Hep B and BCG vaccines between birth and 1 month of life in agreement with the national immunization calendar.
    Evidence for comparator
    		 Infanrix hexa was chosen as the comparator vaccine as it is currently the licensed hexavalent vaccine in Colombia and Costa Rica.
    Actual start date of recruitment
    03 Aug 2010
    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
    Costa Rica: 442
    Country: Number of subjects enrolled
    Colombia: 933
    Worldwide total number of subjects
    1375
    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)
    1375
    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 subjects were enrolled from 03 August 2010 to 23 November 2010 in 2 clinical centers in Columbia and 1 clinical center in Costa Rica.

    Pre-assignment
    Screening details
    		 A total of 1375 subjects who met all inclusion criteria and 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
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    The investigator (blind observer or assessor) and subject’s parents or guardians did not know the vaccine administered. The assessor was in charge of the assessment of safety held in a separate room and away from where the vaccines were prepared. A nurse/vaccinator was in charge of the preparation and administration of the vaccine(s) in another room away from the assessor. When necessary the scratch off emergency decoding procedure described in the study protocol were to be followed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DTap-IPV-Hep B-PRP~T Batch A
    Arm description
    		 Subjects received a 3-dose primary series of vaccinations with Batch A of diphtheria (D), tetanus (T), pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and 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 one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 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-Hep B-PRP~T Batch B
    Arm description
    		 Subjects received a 3-dose primary series of vaccinations with Batch B of diphtheria (D), tetanus (T), pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 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-Hep B-PRP~T Batch C
    Arm description
    		 Subjects received a 3-dose primary series of vaccinations with Batch C of diphtheria (D), tetanus (T), pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 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, Suspension for injection, Suspension for injection
    Routes of administration
    Intramuscular use, Intramuscular use, Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular. One dose each at 2, 4, and 6 months of age.

    Arm title
    		 Infanrix Hexa
    Arm description
    		 Subjects received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix hexa™
    Investigational medicinal product code
    DTaP-HBV-IPV + Hib 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.

    Number of subjects in period 1
    		DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
    Started
    344
    344
    342
    345
    Completed
    331
    334
    333
    338
    Not completed
    13
    10
    9
    7
         Consent withdrawn by subject
    10
    6
    4
    6
         Adverse event, non-fatal
    -
    -
    1
    -
         Lost to follow-up
    3
    4
    3
    1
         Protocol deviation
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTap-IPV-Hep B-PRP~T Batch A
    Reporting group description
    		 Subjects received a 3-dose primary series of vaccinations with Batch A of diphtheria (D), tetanus (T), pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and 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 one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.

    Reporting group title
    DTaP-IPV-Hep B-PRP~T Batch B
    Reporting group description
    		 Subjects received a 3-dose primary series of vaccinations with Batch B of diphtheria (D), tetanus (T), pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.

    Reporting group title
    DTaP-IPV-Hep B-PRP~T Batch C
    Reporting group description
    		 Subjects received a 3-dose primary series of vaccinations with Batch C of diphtheria (D), tetanus (T), pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.

    Reporting group title
    Infanrix Hexa
    Reporting group description
    		 Subjects received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.

    Reporting group values
    		 DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa Total
    Number of subjects
    		 344 344 342 345 1375
    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)
    		 344 344 342 345 1375
        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: days
        arithmetic mean (standard deviation)
    		 58.8 ( 3.49 ) 58.7 ( 3.25 ) 58.5 ( 3.16 ) 58.7 ( 3.31 ) -
    Gender categorical
    Units: Subjects
        Female
    		 161 165 152 156 634
        Male
    		 183 179 190 189 741

    End points

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    End points reporting groups
    Reporting group title
    DTap-IPV-Hep B-PRP~T Batch A
    Reporting group description
    		 Subjects received a 3-dose primary series of vaccinations with Batch A of diphtheria (D), tetanus (T), pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and 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 one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.

    Reporting group title
    DTaP-IPV-Hep B-PRP~T Batch B
    Reporting group description
    		 Subjects received a 3-dose primary series of vaccinations with Batch B of diphtheria (D), tetanus (T), pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.

    Reporting group title
    DTaP-IPV-Hep B-PRP~T Batch C
    Reporting group description
    		 Subjects received a 3-dose primary series of vaccinations with Batch C of diphtheria (D), tetanus (T), pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.

    Reporting group title
    Infanrix Hexa
    Reporting group description
    		 Subjects received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.

    Primary: Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™

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    End point title
    		 Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™ [1]
    End point description
    Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination
    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
    		 DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
    Number of subjects analysed
    312
    310
    313
    316
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Hep B Pre-dose 1
    4.02 (3.5 to 4.61)
    4.07 (3.58 to 4.62)
    4.93 (4.2 to 5.79)
    4.3 (3.68 to 5.03)
        Anti-Hep B Post-dose 3
    3048 (2672 to 3476)
    2801 (2467 to 3181)
    3202 (2794 to 3668)
    2766 (2466 to 3102)
    No statistical analyses for this end point

    Primary: Number of Subjects With Seroprotection or Vaccine Response After Vaccination With DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa Vaccine

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    End point title
    		 Number of Subjects With Seroprotection or Vaccine Response After Vaccination With DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa Vaccine [2]
    End point description
    Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).
    End point type
    Primary
    End point timeframe
    30 Days 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
    Number of subjects analysed
    312
    310
    313
    316
    Units: Participants
    number (not applicable)
        Anti-Diphtheria (N = 310, 310, 312, 315)
    310
    310
    312
    315
        Anti-Tetanus (N = 311, 310, 311, 314)
    311
    310
    311
    314
        Anti-PT (N = 308, 309, 308, 312)
    304
    299
    299
    307
        Anti-FHA (N = 306, 306, 304, 311)
    306
    305
    303
    309
        Anti-Polio 1 (N = 310, 309, 308, 311)
    310
    309
    308
    311
        Anti-Polio 2 (N = 309, 309, 307, 312)
    309
    309
    307
    312
        Anti-Polio 3 (N = 310, 309, 307, 312)
    310
    309
    307
    311
        Anti-Hep B (N = 312, 310, 312, 316)
    311
    310
    310
    316
        Anti-PRP (N = 312, 310, 312, 316)
    299
    298
    287
    303
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies After Vaccination With DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies After Vaccination With DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa Vaccine
    End point description
    Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and 30 days post-dose 3
    End point values
    		 DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
    Number of subjects analysed
    312 [3]
    310 [4]
    313 [5]
    316 [6]
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Diphtheria Pre-dose 1 (N= 312, 308, 311, 315)
    0.599 (0.513 to 0.699)
    0.596 (0.505 to 0.703)
    0.641 (0.547 to 0.752)
    0.63 (0.53 to 0.749)
        Anti-Diphtheria Post-dose 3 (N=310, 310, 312, 315)
    0.252 (0.224 to 0.285)
    0.279 (0.247 to 0.316)
    0.228 (0.201 to 0.26)
    0.24 (0.214 to 0.269)
        Anti-Tetanus Post-dose 3 (N = 311, 310, 311, 314)
    1.66 (1.54 to 1.78)
    1.55 (1.43 to 1.68)
    1.45 (1.33 to 1.59)
    1.8 (1.69 to 1.93)
        Anti-PT Pre-dose 1 (N = 308, 309, 310, 314)
    3.02 (2.65 to 3.45)
    3.5 (3.03 to 4.04)
    3.54 (3.1 to 4.05)
    3.11 (2.7 to 3.59)
        Anti-PT Post-dose 3 (N = 312, 310, 311, 314)
    102 (96.1 to 108)
    103 (95.9 to 110)
    102 (95 to 110)
    98.9 (92.3 to 106)
        Anti-FHA Pre-dose 1(N = 307, 307, 307, 312)
    5.36 (4.77 to 6.02)
    5.66 (5.01 to 6.39)
    5.76 (5.12 to 6.49)
    5.13 (4.61 to 5.7)
        Anti-FHA Post-dose 3 (N=311, 309, 310, 315)
    186 (174 to 199)
    175 (163 to 188)
    183 (171 to 197)
    118 (110 to 127)
        Anti-Polio 1 Post-dose 3 (N = 310, 309, 308, 311)
    755 (674 to 847)
    655 (580 to 739)
    636 (561 to 722)
    1298 (1151 to 1464)
        Anti-Polio 2 Post-dose 3 (N = 309, 309, 307, 312)
    1190 (1054 to 1344)
    1232 (1101 to 1379)
    1120 (994 to 1261)
    1981 (1756 to 2234)
        Anti-Polio 3 Post-dose 3 (N = 310, 309, 307, 312)
    1102 (972 to 1250)
    1119 (975 to 1284)
    1097 (963 to 1250)
    1944 (1680 to 2249)
        Anti-PRP Post-dose 3 (N = 312, 310, 312, 316)
    3.37 (2.8 to 4.05)
    4.02 (3.35 to 4.82)
    3.33 (2.72 to 4.07)
    2.24 (1.9 to 2.64)
    Notes
    [3] - Per Protocol Analysis Set
    [4] - Per Protocol Analysis Set
    [5] - Per Protocol Analysis Set
    [6] - Per Protocol Analysis Set
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa Vaccine

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    End point title
    		 Number of Subjects Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa Vaccine
    End point description
    Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 7 after each dose
    End point values
    		 DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
    Number of subjects analysed
    344 [7]
    343 [8]
    342
    345
    Units: Participants
    number (not applicable)
        Pain Post-dose 1 (N = 338, 341, 340, 344)
    199
    194
    216
    185
        Pain Post-dose 2 (N = 333, 337, 335, 340)
    180
    196
    203
    188
        Pain Post-dose 3 (N = 331, 331, 334, 337)
    168
    163
    162
    147
        Grade 3 Pain Post Dose 1 (N = 338, 341, 344, 344)
    21
    22
    22
    7
        Grade 3 Pain Post Dose 3 (N=331, 331, 334, 338)
    10
    9
    8
    8
        Erythema Post-dose 1 (N = 338, 341, 340, 344)
    72
    63
    82
    52
        Erythema Post-dose 2 (N = 333, 337, 335, 340)
    87
    78
    80
    67
        Erythema Post-dose 3 (N = 331, 331, 334, 337)
    85
    79
    96
    68
        Grade 3 Erythema Post-dose 1(N=338, 341, 340, 344)
    2
    3
    2
    0
        Grade 3 Erythema Post-dose 3(N=331, 331, 334, 337)
    0
    0
    1
    0
        Swelling Post dose 1 (N = 338, 341, 340, 344)
    47
    30
    47
    33
        Swelling Post dose 2 (N = 333, 337, 335, 340)
    44
    35
    45
    44
        Swelling Post dose 3 (N = 331, 331, 334, 337)
    43
    34
    48
    42
        Grade 3 Swelling Post-dose 1(N=338, 341, 340, 344)
    2
    3
    2
    0
        Grade 3 Swelling post-dose 3(N=331, 331, 340, 338)
    0
    0
    0
    0
        Pyrexia Post dose 1 (N = 338, 341, 340, 344)
    46
    42
    68
    46
        Pyrexia Post dose 2 (N = 333, 337, 335, 340)
    70
    68
    68
    70
        Pyrexia Post dose 3 (N = 331, 331, 333, 337)
    67
    63
    72
    65
        Grade 3 Pyrexia Post-dose 1 (N=338, 341, 340, 344)
    2
    0
    0
    0
        Grade 3 Pyrexia Post-dose 3 (N=331, 331, 333, 337)
    4
    1
    1
    2
        Vomiting Post dose 1 (N = 338, 341, 340, 344)
    85
    90
    86
    94
        Vomiting Post dose 2 (N = 333, 337, 335, 340)
    58
    80
    64
    62
        Vomiting Post dose 3 (N = 331, 331, 334, 337)
    32
    58
    46
    39
        Grade 3 Vomiting Post-dose 1(N=338, 341, 340, 344)
    4
    5
    6
    5
        Grade 3 Vomiting post-dose 3(N=331, 331, 334, 337)
    3
    1
    2
    2
        Crying Post dose 1 (N = 338, 341, 340, 344)
    198
    186
    189
    161
        Crying Post dose 2 (N = 333, 337, 335, 340)
    163
    179
    169
    161
        Crying Post dose 3 (N = 331, 331, 334, 337)
    141
    145
    142
    120
        Grade 3 Crying Post-dose 1 (N =338, 341, 340, 344)
    15
    10
    23
    9
        Grade 3 Crying Post-dose 3 (N =331, 331, 334, 337)
    8
    6
    10
    6
        Somnolence Post dose 1 (N = 338, 341, 341, 344)
    159
    146
    160
    147
        Somnolence Post dose 2 (N = 333, 337, 335, 340)
    109
    108
    110
    111
        Somnolence Post dose 3 (N = 331, 331, 334, 337)
    85
    99
    96
    81
        Grad 3 Somnolence Post-dose 1 N=338, 341, 341, 344
    3
    14
    19
    9
        Grad 3 Somnolence Post-dose 3 N=331, 331, 334, 337
    5
    2
    4
    4
        Anorexia Post dose 1 (N = 338, 341, 341, 344)
    78
    97
    96
    75
        Anorexia Post dose 2 (N = 333, 337, 335, 340)
    75
    93
    86
    74
        Anorexia Post dose 3 (N = 331, 331, 334, 337)
    63
    64
    60
    54
        Grade 3 Anorexia Post-dose 1(N=338, 341, 341, 344)
    3
    4
    8
    3
        Grade 3 Anorexia Post-dose 3(N=331, 331, 334, 337)
    4
    7
    4
    3
        Irritability Post dose 1 (N = 338, 341, 341, 344)
    208
    206
    208
    180
        Irritability Post dose 2 (N = 333, 337, 335, 340)
    193
    199
    191
    193
        Irritability Post dose 3 (N = 331, 332, 334, 337)
    155
    161
    154
    144
        Grd 3 Irritability Post-dose 1N=338, 341, 341, 344
    15
    17
    20
    8
        Grd 3 Irritability Post-dose 3N=331, 332, 334, 337
    11
    13
    12
    5
    Notes
    [7] - A participant randomized to Batch B got the Batch A vaccine.
    [8] - A participant randomized to Batch B got the Batch A vaccine.
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™ Vaccine

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    End point title
    		 Number of Subjects Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™ Vaccine
    End point description
    Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 7 post each vaccination
    End point values
    		 DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
    Number of subjects analysed
    344 [9]
    341 [10]
    342
    345
    Units: Participants
    number (not applicable)
        Pain Post-dose 1 (N = 338, 341, 340, 344)
    171
    173
    184
    169
        Grade 3 Pain Post-dose 1 (N = 338, 341, 340, 344)
    15
    15
    16
    8
        Pain Post-dose 2 (N = 333, 337, 335, 340)
    160
    183
    180
    174
        Grade 3 Pain Post-dose 2 (N = 333, 337, 335, 340)
    14
    17
    16
    13
        Pain Post-dose 3 (N =331, 331, 334, 337)
    146
    105
    146
    125
        Grade 3 Pain Post-dose 3 (N = 331, 331, 334, 337)
    8
    9
    10
    7
        Erythema Post-dose 1 (N = 338, 341, 340, 344)
    47
    48
    55
    42
        Grade 3 Erythema Post-dose 1 (N=338, 341, 340, 344
    0
    1
    2
    0
        Erythema Post-dose 2 (N = 333, 337, 335, 340)
    65
    55
    62
    53
        Grade 3 Erythema Post-dose 2 (N=333, 337, 335, 340
    1
    0
    0
    0
        Erythema Post-dose 3 (N = 331, 331, 334, 337)
    63
    57
    69
    49
        Grade 3 Erythema Post-dose 3 (N=331, 331, 334, 337
    1
    1
    0
    0
        Swelling Post-dose 1 (N = 338, 341, 340, 344)
    34
    21
    33
    31
        Grade 3 Swelling Post-dose 1 (N=338, 341, 340, 344
    0
    0
    2
    1
        Swelling Post-dose 2 (N = 333, 337, 335, 340)
    32
    28
    36
    32
        Grade 3 Swelling Post-dose 2 (N=333, 337, 335, 340
    0
    0
    1
    0
        Swelling Post-dose 3 (N = 331, 331, 334, 337)
    27
    29
    36
    29
        Grade 3 Swelling Post-dose 3 (N=331, 331, 334, 337
    0
    0
    0
    0
    Notes
    [9] - A participant randomized to Batch B got the Batch A vaccine
    [10] - A participant randomized to Batch B got the Batch A vaccine
    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 Dose 1 through up to 6 months after the last dose.
    Adverse event reporting additional description
    A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    DTap-IPV-Hep B-PRP~T Batch A
    Reporting group description
    		 Subjects received a 3-dose primary series of vaccinations with Batch A of diphtheria (D), tetanus (T), pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and 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 one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.

    Reporting group title
    DTaP-IPV-Hep B-PRP~T Batch B
    Reporting group description
    		 Subjects received a 3-dose primary series of vaccinations with Batch B of diphtheria (D), tetanus (T), pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.

    Reporting group title
    DTaP-IPV-Hep B-PRP~T Batch C
    Reporting group description
    		 Subjects received a 3-dose primary series of vaccinations with Batch C of diphtheria (D), tetanus (T), pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.

    Reporting group title
    Infanrix Hexa
    Reporting group description
    		 Subjects received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.

    Serious adverse events
    		 DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 345 (2.90%)
    14 / 343 (4.08%)
    16 / 342 (4.68%)
    10 / 345 (2.90%)
         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
    Thermal burn
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 343 (0.29%)
    0 / 342 (0.00%)
    0 / 345 (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
    Cerebral Atrophy Congenital
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    1 / 342 (0.29%)
    0 / 345 (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
    Cardiac disorders
    Cardiac Failure
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    1 / 342 (0.29%)
    0 / 345 (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
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 345 (0.00%)
    2 / 343 (0.58%)
    1 / 342 (0.29%)
    0 / 345 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 343 (0.00%)
    0 / 342 (0.00%)
    0 / 345 (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
    Febrile convulsion
         subjects affected / exposed
    2 / 345 (0.58%)
    1 / 343 (0.29%)
    0 / 342 (0.00%)
    1 / 345 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 343 (0.29%)
    0 / 342 (0.00%)
    0 / 345 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden infant death syndrome
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    1 / 342 (0.29%)
    0 / 345 (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 / 1
    0 / 0
    Gastrointestinal disorders
    Abdominal strangulated hernia
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    0 / 342 (0.00%)
    1 / 345 (0.29%)
         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
    Diarrhoea
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    0 / 342 (0.00%)
    1 / 345 (0.29%)
         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
    Enteritis
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 343 (0.29%)
    0 / 342 (0.00%)
    1 / 345 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 343 (0.29%)
    0 / 342 (0.00%)
    1 / 345 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    1 / 342 (0.29%)
    0 / 345 (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
    Vomiting
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    1 / 342 (0.29%)
    0 / 345 (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
    Asthma
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    1 / 342 (0.29%)
    0 / 345 (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
    Asthmatic crisis
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 343 (0.29%)
    0 / 342 (0.00%)
    0 / 345 (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
    Diaphragmatic hernia
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 343 (0.00%)
    0 / 342 (0.00%)
    0 / 345 (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
    Foreign body aspiration
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    0 / 342 (0.00%)
    1 / 345 (0.29%)
         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
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 343 (0.29%)
    0 / 342 (0.00%)
    0 / 345 (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
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    5 / 345 (1.45%)
    6 / 343 (1.75%)
    9 / 342 (2.63%)
    8 / 345 (2.32%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 343 (0.00%)
    0 / 342 (0.00%)
    0 / 345 (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
    Dengue fever
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 343 (0.00%)
    0 / 342 (0.00%)
    1 / 345 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    1 / 342 (0.29%)
    0 / 345 (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
    1 / 345 (0.29%)
    0 / 343 (0.00%)
    0 / 342 (0.00%)
    0 / 345 (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
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    0 / 342 (0.00%)
    1 / 345 (0.29%)
         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
    Kawasaki's disease
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    1 / 342 (0.29%)
    0 / 345 (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
    Otitis media acute
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 343 (0.29%)
    0 / 342 (0.00%)
    0 / 345 (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
    Periorbital cellulitis
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    0 / 342 (0.00%)
    1 / 345 (0.29%)
         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
    Pneumonia
         subjects affected / exposed
    4 / 345 (1.16%)
    5 / 343 (1.46%)
    11 / 342 (3.22%)
    5 / 345 (1.45%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia primary atypical
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 343 (0.29%)
    0 / 342 (0.00%)
    1 / 345 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 343 (0.00%)
    1 / 342 (0.29%)
    0 / 345 (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
    Pyelonephritis acute
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    1 / 342 (0.29%)
    0 / 345 (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
    Urinary tract infection
         subjects affected / exposed
    3 / 345 (0.87%)
    2 / 343 (0.58%)
    2 / 342 (0.58%)
    3 / 345 (0.87%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 343 (0.00%)
    1 / 342 (0.29%)
    0 / 345 (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
    Viral infection
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 343 (0.29%)
    1 / 342 (0.29%)
    0 / 345 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    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-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    208 / 345 (60.29%)
    206 / 343 (60.06%)
    216 / 342 (63.16%)
    193 / 345 (55.94%)
    Nervous system disorders
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    159 / 338 (47.04%)
    146 / 341 (42.82%)
    160 / 341 (46.92%)
    147 / 344 (42.73%)
         occurrences all number
    159
    146
    160
    147
    General disorders and administration site conditions
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    87 / 338 (25.74%)
    79 / 341 (23.17%)
    96 / 340 (28.24%)
    68 / 344 (19.77%)
         occurrences all number
    87
    79
    96
    68
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    199 / 338 (58.88%)
    196 / 341 (57.48%)
    216 / 340 (63.53%)
    188 / 344 (54.65%)
         occurrences all number
    199
    196
    216
    188
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    47 / 338 (13.91%)
    35 / 341 (10.26%)
    48 / 340 (14.12%)
    44 / 344 (12.79%)
         occurrences all number
    47
    35
    48
    44
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    208 / 338 (61.54%)
    206 / 341 (60.41%)
    208 / 341 (61.00%)
    193 / 344 (56.10%)
         occurrences all number
    208
    206
    208
    193
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    70 / 338 (20.71%)
    68 / 341 (19.94%)
    72 / 340 (21.18%)
    70 / 344 (20.35%)
         occurrences all number
    70
    68
    72
    70
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    85 / 338 (25.15%)
    90 / 341 (26.39%)
    86 / 340 (25.29%)
    94 / 344 (27.33%)
         occurrences all number
    85
    90
    86
    94
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    21 / 345 (6.09%)
    17 / 343 (4.96%)
    23 / 342 (6.73%)
    17 / 345 (4.93%)
         occurrences all number
    24
    17
    25
    18
    Psychiatric disorders
    Crying
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    198 / 338 (58.58%)
    186 / 341 (54.55%)
    189 / 340 (55.59%)
    161 / 344 (46.80%)
         occurrences all number
    198
    186
    189
    161
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    99 / 345 (28.70%)
    96 / 343 (27.99%)
    90 / 342 (26.32%)
    87 / 345 (25.22%)
         occurrences all number
    125
    132
    116
    105
    Metabolism and nutrition disorders
    Anorexia
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    75 / 338 (22.19%)
    97 / 341 (28.45%)
    96 / 341 (28.15%)
    75 / 344 (21.80%)
         occurrences all number
    75
    97
    96
    75
    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.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Oct 2009
    Protocol was updated with a requirement to collect additional data on the intake of antipyretics (category 1 medication) to perform an observational analysis on the potential impact of antipyretics prophylaxis on the immunogenicity of DTaP-IPV-Hep B-PRP-T.
    09 Mar 2010
    A modification in the planned interim analysis for the study.
    02 Aug 2010
    A change in the design from a double-blind to an observer blinded 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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