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    Clinical Trial Results:
    A randomised, controlled, double blind study of the immunogenicity and safety of Pediacel™, a combined diphtheria, tetanus, five component acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed) compared to Infanrix™–IPV+Hib when both vaccines are given to infants using a three dose immunisation schedule (“Nordic schedule” 3-5-12 months)

    Summary
    EudraCT number
    		 2005-004133-17
    Trial protocol
    		 FI   SE  
    Global end of trial date
    28 May 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    27 Nov 2016
    First version publication date
    30 Jan 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Change of primary and back up users

    Trial information

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    Trial identification
    Sponsor protocol code
    A5I15
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00287092
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc
    Sponsor organisation address
    1 Discovery Drive, Swiftwater, United States, 18370
    Public contact
    Associate Vice President, Clinical Development, Sanofi Pasteur Inc, 1 570 957 3570, emilia.jordanov@sanofipasteur.com
    Scientific contact
    Associate Vice President, Clinical Development, Sanofi Pasteur Inc, 1 570 957 3570, emilia.jordanov@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Sep 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunogenicity post-dose 3 of PEDIACEL® (Group A) and Infanrix™–IPV+Hib (Group B) when administered to infants at 3, 5 and 12 months of age.
    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
    		 The three-dose vaccination schedule assessed in this study is the vaccine schedule used in Nordic countries for infant routine vaccinations.
    Evidence for comparator
    		 The active comparator, Infanrix-IPV+Hib, is a current pentavalent standard of care vaccine in Nordic countries.
    Actual start date of recruitment
    10 Feb 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
    Sweden: 15
    Country: Number of subjects enrolled
    Finland: 790
    Worldwide total number of subjects
    805
    EEA total number of subjects
    805
    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)
    805
    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 10 February 2006 to 28 May 2007 in 12 clinical centers in Finland and 1 clinical center in Sweden.

    Pre-assignment
    Screening details
    		 A total of 807 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. However, Two subjects randomised to the PEDIACEL group did not report safety data and therefore were not part of the safety analysis set and in this report.

    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, Assessor, Investigator
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PEDIACEL
    Arm description
    		 Subjects who received 3 doses of PEDIACEL (diphtheria, tetanus, 5 component acellular pertussis, inactivated poliomyelitis Haemophilus influenzae type B conjugate vaccine [adsorbed]) administered at 3, 5, and 12 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PEDIACEL®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection in the anterolateral aspect of the upper thigh at 3 and 5 months and in the deltoid muscle at 12 months.

    Arm title
    		 Infanrix-IPV+Hib
    Arm description
    		 Subjects who received Infanrix-IPV+Hib (diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and adsorbed conjugated Haemophilus influenzae type b vaccine) administered at 3, 5, and 12 months.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix™-IPV+Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection in the anterolateral aspect of the upper thigh at 3 and 5 months and in the deltoid muscle at 12 months.

    Number of subjects in period 1
    		PEDIACEL Infanrix-IPV+Hib
    Started
    400
    405
    Completed
    380
    393
    Not completed
    20
    12
         Adverse event, serious fatal
    7
    -
         Consent withdrawn by subject
    7
    4
         Adverse event, non-fatal
    4
    5
         Lost to follow-up
    1
    2
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PEDIACEL
    Reporting group description
    		 Subjects who received 3 doses of PEDIACEL (diphtheria, tetanus, 5 component acellular pertussis, inactivated poliomyelitis Haemophilus influenzae type B conjugate vaccine [adsorbed]) administered at 3, 5, and 12 months.

    Reporting group title
    Infanrix-IPV+Hib
    Reporting group description
    		 Subjects who received Infanrix-IPV+Hib (diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and adsorbed conjugated Haemophilus influenzae type b vaccine) administered at 3, 5, and 12 months.

    Reporting group values
    		 PEDIACEL Infanrix-IPV+Hib Total
    Number of subjects
    		 400 405 805
    Age categorical
    The number of subjects reported are based on the Safety Analysis Set (N=805).
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 400 405 805
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 2.9 ± 0.27 2.9 ± 0.27 -
    Gender categorical
    Units: Subjects
        Female
    		 179 194 373
        Male
    		 221 211 432

    End points

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    End points reporting groups
    Reporting group title
    PEDIACEL
    Reporting group description
    		 Subjects who received 3 doses of PEDIACEL (diphtheria, tetanus, 5 component acellular pertussis, inactivated poliomyelitis Haemophilus influenzae type B conjugate vaccine [adsorbed]) administered at 3, 5, and 12 months.

    Reporting group title
    Infanrix-IPV+Hib
    Reporting group description
    		 Subjects who received Infanrix-IPV+Hib (diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and adsorbed conjugated Haemophilus influenzae type b vaccine) administered at 3, 5, and 12 months.

    Primary: Number of Subjects with Seroprotection Against Purified Polyribosylribitol Phosphate Capsular Polysaccharide (PRP), Diphtheria, Tetanus and Polio Antigens Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Number of Subjects with Seroprotection Against Purified Polyribosylribitol Phosphate Capsular Polysaccharide (PRP), Diphtheria, Tetanus and Polio Antigens Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine [1]
    End point description
    Antibody titers were measured for polyribosylribitol phosphate capsular polysaccharide (PRP) using radioimmunoassay, for diphtheria and poliovirus by serum neutralization (SN) assay, and for tetanus by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥1.0 µg/mL for PRP, ≥0.1 IU/mL for diphtheria and tetanus, and ≥1:8 [1/dil] for poliovirus 1, 2, and 3.
    End point type
    Primary
    End point timeframe
    1 month post-dose 3
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    325
    341
    Units: Subjects
    number (not applicable)
        PRP (≥1.0 µg/mL)
    303
    330
        Diphtheria toxoid (≥0.1 IU/mL)
    309
    308
        Tetanus toxoid (≥0.1 IU/mL)
    325
    339
        Polio 1 (≥1:8 1/dil)
    322
    336
        Polio 2 (≥1:8 1/dil)
    322
    336
        Polio 3 (≥1:8 1/dil)
    319
    335
    No statistical analyses for this end point

    Primary: Number of Subjects with Seroresponse Against Pertussis Antigens Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Number of Subjects with Seroresponse Against Pertussis Antigens Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine [2]
    End point description
    Antibody titers were measured for pertussis antigens by ELISA. Seroresponse was defined as post-dose 3 ≥ 4 EU/mL if pre-dose 1 < 4 EU/mL or post-dose 3 ≥ pre-dose 1 if pre-dose 1 ≥ 4 EU/mL for pertussis toxoid (PT), pertactin (PRN), and fimbriae types 2 and 3 (FIM) and for filamentous haemagglutinin (FHA) seroresponse was defined as post-dose 3 ≥ 3 EU/mL if pre-dose 1 < 3 EU/mL or post-dose 3 ≥ pre-dose 1 if pre-dose 1 ≥ 3 EU/mL.
    End point type
    Primary
    End point timeframe
    1 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    325
    341
    Units: Subjects
    number (not applicable)
        PT
    318
    340
        FHA
    321
    340
        PRN
    311
    335
        FIM
    310
    12
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Against Polyribosylribitol Phosphate Capsular Polysaccharide (PRP) Antigens Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Against Polyribosylribitol Phosphate Capsular Polysaccharide (PRP) Antigens Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine
    End point description
    Antibody titers were measured for PRP using radioimmunassay.
    End point type
    Secondary
    End point timeframe
    1 month post-dose 3
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    325
    341
    Units: Titers
    geometric mean (confidence interval 95%)
        PRP (µg/mL)
    12.2 (10.46 to 14.24)
    17.54 (15.38 to 20.01)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Seroprotection Against Purified Polyribosylribitol Phosphate Capsular Polysaccharide (PRP), Diphtheria, Tetanus and Polio Antigens Post-dose 2 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Number of Subjects with Seroprotection Against Purified Polyribosylribitol Phosphate Capsular Polysaccharide (PRP), Diphtheria, Tetanus and Polio Antigens Post-dose 2 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine
    End point description
    Antibody titers were measured for polyribosylribitol phosphate capsular polysaccharide (PRP) using radioimmunassay, for diphtheria and poliovirus by serum neutralization (SN) assay, and for tetanus by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as post-dose 2 titers ≥0.15 µg/mL for PRP, ≥0.01 IU/mL for diphtheria and tetanus, and ≥1:8 [1/dil] for poliovirus 1, 2, and 3.
    End point type
    Secondary
    End point timeframe
    1 month post-dose 2
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    325
    341
    Units: Subjects
    number (not applicable)
        PRP (≥0.15 µg/mL)
    214
    234
        Diphtheria toxoid (≥0.01 IU/mL)
    297
    318
        Tetanus toxoid (≥0.01 IU/mL)
    316
    334
        Polio 1 (≥1:8 1/dil)
    304
    323
        Polio 2 (≥1:8 1/dil)
    290
    312
        Polio 3 (≥1:8 1/dil)
    300
    321
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Against Purified Polyribosylribitol Phosphate Capsular Polysaccharide (PRP), Diphtheria, Tetanus and Polio Antigens Post-dose 2 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Against Purified Polyribosylribitol Phosphate Capsular Polysaccharide (PRP), Diphtheria, Tetanus and Polio Antigens Post-dose 2 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine
    End point description
    Antibody titers were measured for PRP using radioimmunassay, for diphtheria and poliovirus by serum neutralization (SN) assay, and for tetanus by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Secondary
    End point timeframe
    1 month post-dose 2
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    325
    341
    Units: Titers
    geometric mean (confidence interval 95%)
        PRP (µg/mL)
    0.4 (0.33 to 0.5)
    0.44 (0.36 to 0.54)
        Diphtheria toxoid (IU/mL)
    0.07 (0.06 to 0.08)
    0.05 (0.04 to 0.05)
        Tetanus toxoid (IU/mL)
    0.43 (0.39 to 0.47)
    0.66 (0.61 to 0.72)
        Polio 1 (1/dil)
    100.92 (83.5 to 121.99)
    173.13 (142.53 to 210.3)
        Polio 2 (1/dil)
    34.48 (29.1 to 40.86)
    37.77 (32.02 to 44.56)
        Polio 3 (1/dil)
    89.51 (74.07 to 108.15)
    158.7 (129.63 to 194.29)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Seroresponse Against Pertussis Antigens Post-dose 2 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Number of Subjects with Seroresponse Against Pertussis Antigens Post-dose 2 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine
    End point description
    Antibody titers were measured for pertussis antigens by ELISA. Seroresponse was defined as post-dose 2 ≥ 4 EU/mL if pre-dose 1 < 4 EU/mL or post-dose 2 ≥ pre-dose 1 if pre-dose 1 ≥ 4 EU/mL for pertussis toxoid (PT), pertactin (PRN), and fimbriae types 2 and 3 (FIM) and for filamentous haemagglutinin (FHA) seroresponse was defined as post-dose 2 ≥ 3 EU/mL if pre-dose 1 < 3 EU/mL or post-dose 2 ≥ pre-dose 1 if pre-dose 1 ≥ 3 EU/mL.
    End point type
    Secondary
    End point timeframe
    1 month post-dose 2
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    325
    341
    Units: Subjects
    number (not applicable)
        PT
    306
    326
        FHA
    311
    320
        PRN
    246
    300
        FIM
    297
    8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with ≥ 2- and ≥ 4-Fold Increases in Antibodies Against Pertussis Antigens Post-dose 2 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Percentage of Subjects with ≥ 2- and ≥ 4-Fold Increases in Antibodies Against Pertussis Antigens Post-dose 2 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine
    End point description
    Antibody titers were measured for pertussis antigens (pertussis toxoid [PT], filamentous haemagglutinin [FHA], pertactin [PRN], and fimbriae types 2 and 3 [FIM]) by ELISA. A fold increase was defined as post-dose 2/pre-dose 1.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 to 1 month post-dose 2
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    325
    341
    Units: Percentage of subjects
    number (not applicable)
        PT ≥2-fold increase
    94.9
    96.4
        PT ≥4-fold increase
    87.7
    90.4
        FHA ≥2-fold increase
    94.9
    92.7
        FHA ≥4-fold increase
    85.7
    84.9
        PRN ≥2-fold increase
    70.4
    85.5
        PRN ≥4-fold increase
    55.3
    75.2
        FIM ≥2-fold increase
    91
    0.6
        FIM ≥4-fold increase
    85.5
    0
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Against Pertussis Antigens Post-dose 2 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Against Pertussis Antigens Post-dose 2 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine
    End point description
    Antibody titers were measured for pertussis antigens (pertussis toxoid [PT], filamentous haemagglutinin [FHA], pertactin [PRN], and fimbriae types 2 and 3 [FIM]) by ELISA.
    End point type
    Secondary
    End point timeframe
    1 month post-dose 2
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    325
    341
    Units: Titers
    geometric mean (confidence interval 95%)
        PT (EU/mL)
    77.3 (71.18 to 83.94)
    72.76 (67.63 to 78.28)
        FHA (EU/mL)
    61.54 (57.12 to 66.29)
    73.72 (68.29 to 79.57)
        PRN (EU/mL)
    25.21 (21.97 to 28.93)
    56.89 (50.66 to 63.89)
        FIM (EU/mL)
    131 (115.09 to 149.12)
    2.59 (2.43 to 2.75)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Seroprotection Against Purified Polyribosylribitol Phosphate Capsular Polysaccharide (PRP), Diphtheria and Tetanus Antigens Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Number of Subjects with Seroprotection Against Purified Polyribosylribitol Phosphate Capsular Polysaccharide (PRP), Diphtheria and Tetanus Antigens Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine
    End point description
    Antibody titers were measured for PRP using radioimmunassay, for diphtheria by serum neutralization (SN) assay, and for tetanus by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as post-dose 3 titers ≥0.15 µg/mL for PRP and ≥0.01 IU/mL for diphtheria and tetanus.
    End point type
    Secondary
    End point timeframe
    1 month post-dose 3
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    325
    341
    Units: Subjects
    number (not applicable)
        PRP (≥0.15 µg/mL)
    322
    340
        Diphtheria toxoid (≥0.01 IU/mL)
    319
    334
        Tetanus toxoid (≥0.01 IU/mL)
    325
    340
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Diphtheria, Tetanus and Polio Antibodies Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Diphtheria, Tetanus and Polio Antibodies Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine
    End point description
    Antibody titers were measured for diphtheria and poliovirus by serum neutralization (SN) assay and for tetanus by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Secondary
    End point timeframe
    1 month post-dose 3
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    325
    341
    Units: Titers
    geometric mean (confidence interval 95%)
        Diphtheria toxoid (IU/mL)
    1.28 (1.09 to 1.5)
    0.7 (0.6 to 0.82)
        Tetanus toxoid (IU/mL)
    3.63 (3.35 to 3.93)
    3.91 (3.63 to 4.22)
        Polio 1 (1/dil)
    1260.2 (1081.59 to 1468.31)
    3419.53 (2987.52 to 3914.02)
        Polio 2 (1/dil)
    853.26 (709.42 to 1026.26)
    1870.3 (1584.01 to 2208.33)
        Polio 3 (1/dil)
    1204.14 (991.42 to 1462.51)
    3536.37 (2984.8 to 4189.86)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with ≥ 2- and ≥ 4-Fold Increases in Antibodies to Pertussis Antigens Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Percentage of Subjects with ≥ 2- and ≥ 4-Fold Increases in Antibodies to Pertussis Antigens Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine
    End point description
    Antibody titers were measured for pertussis antigens (pertussis toxoid [PT], filamentous haemagglutinin [FHA], pertactin [PRN], and fimbriae types 2 and 3 [FIM]) by ELISA. A fold increase was defined as post-dose 3/pre-dose 1.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 to 1 month post-dose 3
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    325
    341
    Units: Percentage of subjects
    number (not applicable)
        PT ≥2-fold increase
    97.8
    98.5
        PT ≥4-fold increase
    94.7
    96.5
        FHA ≥2-fold increase
    98.8
    99.7
        FHA ≥4-fold increase
    95.7
    96.2
        PRN ≥2-fold increase
    93.8
    97.6
        PRN ≥4-fold increase
    87.2
    94.4
        FIM ≥2-fold increase
    96
    2.4
        FIM ≥4-fold increase
    94.4
    0.3
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Pertussis Antibodies Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Pertussis Antibodies Post-dose 3 Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine
    End point description
    Antibody titers were measured for pertussis antigens (pertussis toxoid [PT], filamentous haemagglutinin [FHA], pertactin [PRN], and fimbriae types 2 and 3 [FIM]) by ELISA.
    End point type
    Secondary
    End point timeframe
    1 month post-dose 3
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    325
    341
    Units: Titers
    geometric mean (confidence interval 95%)
        PT (EU/mL)
    150.3 (138.48 to 163.14)
    118.55 (110.4 to 127.29)
        FHA (EU/mL)
    149.51 (138.45 to 161.46)
    215.55 (200.38 to 231.87)
        PRN (EU/mL)
    98.08 (88.97 to 108.13)
    206.71 (188.42 to 226.78)
        FIM (EU/mL)
    439.64 (384.42 to 502.79)
    2.27 (2.15 to 2.4)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Any Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Percentage of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Any Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine
    End point description
    Solicited Injection Site Reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Temperature (Fever), Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability.
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 7 post any vaccination
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    400
    405
    Units: Percentage of subjects
    number (not applicable)
        Injection site Tenderness
    59.5
    60.2
        Injection site Erythema
    61.3
    62
        Injection site Swelling
    44
    45.9
        Fever (≥38 C)
    68.7
    70.4
        Vomiting
    30.5
    31.1
        Crying abnormal
    78.5
    75.8
        Drowsiness
    76.8
    73.3
        Appetite loss
    56.3
    60.5
        Irritability
    88.8
    89.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Each Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine

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    End point title
    		 Percentage of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Each Vaccination with Either PEDIACEL or Infanrix-IPV+Hib Vaccine
    End point description
    Solicited Injection Site Reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Temperature (Fever), Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability. Grade 3 Injection Site: Tenderness – Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling – ≥5 cm. Grade 3 Solicited Systemic Reactions: Fever - >39.6 C; Vomiting – ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal – >3 hours; Drowsiness – Sleeping most of the time or difficult to wake up; Appetite loss – Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability – Inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 12 months post vaccination
    End point values
    		 PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    400
    405
    Units: Percentage of subjects
    number (not applicable)
        Injection site Tenderness Post-dose 1
    37.6
    29.6
        Grade 3 Injection site Tenderness Post-dose 1
    6.5
    1
        Injection site Tenderness Post-dose 2
    26.2
    26.6
        Grade 3 Injection site Tenderness Post-dose 2
    4.6
    2
        Injection site Tenderness Post-dose 3
    36.2
    46.8
        Grade 3 Injection site Tenderness Post-dose 3
    2.6
    3.3
        Injection site Erythema Post-dose 1
    26.8
    21.7
        Grade 3 Injection site Erythema Post-dose 1
    3
    1.2
        Injection site Erythema Post-dose 2
    33.6
    32.4
        Grade 3 Injection site Erythema Post-dose 2
    0.5
    0.3
        Injection site Erythema Post-dose 3
    47.2
    49.9
        Grade 3 Injection site Erythema Post-dose 3
    3.9
    4.9
        Injection site Swelling Post-dose 1
    20.8
    14.8
        Grade 3 Injection site Swelling Post-dose 1
    2.5
    0.5
        Injection site Swelling Post-dose 2
    22.1
    20.6
        Grade 3 Injection site Swelling Post-dose 2
    1
    0.8
        Injection site Swelling Post-dose 3
    27.6
    34.7
        Grade 3 Injection site Swelling Post-dose 3
    0.8
    3.3
        Fever Post-dose 1
    25.7
    24
        Grade 3 Fever Post-dose 1
    0
    0
        Fever Post-dose 2
    43
    35.5
        Grade 3 Fever Post-dose 2
    0.5
    0.8
        Fever Post-dose 3
    39.8
    53.9
        Grade 3 Fever Post-dose 3
    2.1
    1.8
        Vomiting Post-dose 1
    17.3
    15.3
        Grade 3 Vomiting Post-dose 1
    1
    0.5
        Vomiting Post-dose 2
    14.8
    16.3
        Grade 3 Vomiting Post-dose 2
    0
    0.8
        Vomiting Post-dose 3
    7.9
    11.8
        Grade 3 Vomiting Post-dose 3
    1
    0.3
        Crying abnormal Post-dose 1
    59.6
    52.1
        Grade 3 Crying abnormal Post-dose 1
    3
    2
        Crying abnormal Post-dose 2
    50.1
    45.5
        Grade 3 Crying abnormal Post-dose 2
    1.8
    2.8
        Crying abnormal Post-dose 3
    43.8
    51.2
        Grade 3 Crying abnormal Post-dose 3
    1.6
    2.6
        Drowsiness Post-dose 1
    56.9
    50.9
        Grade 3 Drowsiness Post-dose 1
    2
    2.2
        Drowsiness Post-dose 2
    45.5
    36.7
        Grade 3 Drowsiness Post-dose 2
    1.3
    0.8
        Drowsiness Post-dose 3
    36.7
    47.6
        Grade 3 Drowsiness Post-dose 3
    0.8
    1
        Appetite loss Post-dose 1
    26.8
    24.2
        Grade 3 Appetite loss Post-dose 1
    0.5
    1.5
        Appetite loss Post-dose 2
    26.2
    20.4
        Grade 3 Appetite loss Post-dose 2
    0.8
    1.3
        Appetite loss Post-dose 3
    36.5
    44.7
        Grade 3 Appetite loss Post-dose 3
    4.2
    4.6
        Irritability Post-dose 1
    70.7
    65.4
        Grade 3 Irritability Post-dose 1
    6
    5.4
        Irritability Post-dose 2
    60.8
    57.5
        Grade 3 Irritability Post-dose 2
    4.1
    4.5
        Irritability Post-dose 3
    57
    70.2
        Grade 3 Irritability Post-dose 3
    1.8
    3.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-any vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    PEDIACEL
    Reporting group description
    		 Subjects who received 3 doses of PEDIACEL (diphtheria, tetanus, 5 component acellular pertussis, inactivated poliomyelitis Haemophilus influenzae type B conjugate vaccine [adsorbed]) administered at 3, 5, and 12 months.

    Reporting group title
    Infanrix-IPV+Hib
    Reporting group description
    		 Subjects who received Infanrix-IPV+Hib (diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and adsorbed conjugated Haemophilus influenzae type b vaccine) administered at 3, 5, and 12 months.

    Serious adverse events
    		 PEDIACEL Infanrix-IPV+Hib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    34 / 400 (8.50%)
    22 / 405 (5.43%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Developmental delay
         subjects affected / exposed
    2 / 400 (0.50%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Growth retardation
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 400 (0.00%)
    2 / 405 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body aspiration
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 405 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Medical observation
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 405 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    1 / 400 (0.25%)
    1 / 405 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital atrial septal defect
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patent ductus arteriosus
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 405 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 405 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye disorder
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 405 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 400 (0.00%)
    2 / 405 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 405 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle twitching
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess neck
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    3 / 400 (0.75%)
    1 / 405 (0.25%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 400 (0.50%)
    2 / 405 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis acute
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 405 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    4 / 400 (1.00%)
    3 / 405 (0.74%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 400 (0.50%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    2 / 400 (0.50%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 400 (0.25%)
    1 / 405 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal infection
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 400 (0.50%)
    3 / 405 (0.74%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    3 / 400 (0.75%)
    1 / 405 (0.25%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 405 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 405 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PEDIACEL Infanrix-IPV+Hib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    355 / 400 (88.75%)
    363 / 405 (89.63%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    307 / 400 (76.75%)
    297 / 405 (73.33%)
         occurrences all number
    307
    297
    General disorders and administration site conditions
    Injection site Haemorrhage
         subjects affected / exposed
    26 / 400 (6.50%)
    27 / 405 (6.67%)
         occurrences all number
    28
    27
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    238 / 400 (59.50%)
    244 / 405 (60.25%)
         occurrences all number
    238
    244
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    245 / 400 (61.25%)
    251 / 405 (61.98%)
         occurrences all number
    245
    251
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    176 / 400 (44.00%)
    186 / 405 (45.93%)
         occurrences all number
    176
    186
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    274 / 400 (68.50%)
    285 / 405 (70.37%)
         occurrences all number
    274
    285
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    122 / 400 (30.50%)
    126 / 405 (31.11%)
         occurrences all number
    122
    126
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    314 / 400 (78.50%)
    307 / 405 (75.80%)
         occurrences all number
    314
    307
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    355 / 400 (88.75%)
    363 / 405 (89.63%)
         occurrences all number
    355
    363
    Metabolism and nutrition disorders
    Appetite loss
    alternative assessment type: Systematic
         subjects affected / exposed
    225 / 400 (56.25%)
    245 / 405 (60.49%)
         occurrences all number
    225
    245

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2007
    The assay descriptions of serology testing methodology and outsourcing along with the List of Investigators were updated
    09 May 2007
    The serology testing location, safety definitions, storage conditions of sera, and the List of Investigators were updated. The amended protcol was submitted on 20 December 2007.

    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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