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    Clinical Trial Results:
    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 Co-Administered with Prevenar® to Infants and Toddlers at 2, 3, 4 and 12-18 Months of Age

    Summary
    EudraCT number
    2006-001095-21
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    17 Jun 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Jun 2016
    First version publication date
    17 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A5I16
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00343421
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    1 Discovery Drive, Swiftwater, United States, 18370
    Public contact
    Clinical Team Leader, Sanofi Pasteur Inc., 1 570 957 3570, emilia.jordanov@sanofipasteur.com
    Scientific contact
    Clinical Team Leader, 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?
    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
    28 Apr 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Phase 1. To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®–IPV+Hib when both are co-administered with Prevenar® to infants at 2, 3 and 4 months of age. 2. To compare the post-dose 3 immunogenicity of Prevenar® co-administered with Pediacel® to the post-dose 3 immunogenicity of Prevenar® co-administered with Infanrix®-IPV+Hib in infants at 2, 3 and 4 months of age. 3. To describe the post-dose 3 pertussis antibody responses in both study groups. Booster Phase Not applicable
    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 was also available on site in case of any immediate allergic reactions
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    10 May 2007
    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
    France: 365
    Country: Number of subjects enrolled
    Poland: 219
    Worldwide total number of subjects
    584
    EEA total number of subjects
    584
    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)
    584
    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 for the booster dose from 10 May 2007 to 17 June 2008 for the dose 4 booster at 12 clinic sites in Poland and 53 clinic sites in France.

    Pre-assignment
    Screening details
    A total of 588 subjects who met all inclusion and none of the exclusion criteria were randomized, of which 573 received all 3 doses of study vaccine as randomized. The safety analysis set for all 3 doses included 584 subjects.

    Period 1
    Period 1 title
    Primary phase
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject
    Blinding implementation details
    A double-blind study design was not feasible due to the different presentations of the study vaccines (i.e., vial versus pre-filled syringes). A single-blind study design had no impact on the primary immunogenicity objective. Laboratory personnel were blinded to the vaccine the subject received.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    PEDIACEL
    Arm description
    Infants received PEDIACEL co-administered with Prevenar as a primary series vaccination at 2, 3, and 4 months of age.
    Arm type
    Experimental

    Investigational medicinal product name
    PEDIACEL: Diphtheria, tetanus, five component acellular pertussis, inactivated poliomyelitis and H. influenzae type b conjugate vaccine (adsorbed)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the deltoid muscle, 1 injection each at 2, 3, and 4 months of age.

    Investigational medicinal product name
    Prevenar: Pneumococcal saccharide conjugated vaccine, adsorbed
    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 into the deltoid muscle of the contralateral arm, 1 injection each at 2, 3, and 4 months of age.

    Arm title
    Infanrix-IPV+Hib
    Arm description
    Infants received Infanrix-IPV+Hib coadministered with Prevenar as a primary series vaccination at 2, 3, and 4 months of age.
    Arm type
    Active comparator

    Investigational medicinal product name
    Infanrix-IPV+Hib: Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and adsorbed conjugated H. influenzae type b vaccine
    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 deltoid muscle, 1 injection each at 2, 3, and 4 months of age.

    Investigational medicinal product name
    Prevenar: Pneumococcal saccharide conjugated vaccine, adsorbed
    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 into the deltoid muscle of the contralateral arm, 1 injection each at 2, 3, and 4 months of age.

    Number of subjects in period 1
    PEDIACEL Infanrix-IPV+Hib
    Started
    292
    292
    Completed
    284
    280
    Not completed
    8
    12
         Protocol deviation
             2
             2
         Serious adverse events
             -
             2
         Consent withdrawn by subject
             3
             6
         Lost to follow-up
             2
             2
         Serious adverse event
             1
             -
    Period 2
    Period 2 title
    Booster phase
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject
    Blinding implementation details
    A double-blind study design was not feasible due to the different presentations of the study vaccines (i.e., vial versus pre-filled syringes). A single-blind study design had no impact on the primary immunogenicity objective. Laboratory personnel were blinded to the vaccine the subject received.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    PEDIACEL
    Arm description
    Infants received PEDIACEL co-administered with Prevenar as dose 4 booster at 12-18 months of age.
    Arm type
    Experimental

    Investigational medicinal product name
    PEDIACEL: Diphtheria, tetanus, five component acellular pertussis, inactivated poliomyelitis and H. influenzae type b conjugate vaccine (adsorbed)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the deltoid muscle, booster dose at 12-18 months of age.

    Investigational medicinal product name
    Prevenar: Pneumococcal saccharide conjugated vaccine, adsorbed
    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 into the deltoid muscle of the contralateral arm, booster dose at 12-18 months of age.

    Arm title
    Infanrix-IPV+Hib
    Arm description
    Infants received Infanrix-IPV+Hib coadministered with Prevenar as dose 4 booster at 12-18 months of age.
    Arm type
    Active comparator

    Investigational medicinal product name
    Infanrix-IPV+Hib: Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and adsorbed conjugated H. influenzae type be vaccine
    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 deltoid muscle, booster at 12-18 months of age.

    Investigational medicinal product name
    Prevenar: Pneumococcal saccharide conjugated vaccine, adsorbed
    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 into the deltoid muscle of the contralateral arm, booster dose at 12-18 months of age.

    Number of subjects in period 2 [1]
    PEDIACEL Infanrix-IPV+Hib
    Started
    267
    264
    Completed
    266
    263
    Not completed
    1
    1
         Consent withdrawn by subject
             1
             1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: A total of 37 subjects withdrew from the study between the primary series and the booster dose. (20 subjects from the PEDIACEL Group and 17 subjects from the Infanrix-IPV+Hib group).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PEDIACEL
    Reporting group description
    Infants received PEDIACEL co-administered with Prevenar as a primary series vaccination at 2, 3, and 4 months of age.

    Reporting group title
    Infanrix-IPV+Hib
    Reporting group description
    Infants received Infanrix-IPV+Hib coadministered with Prevenar as a primary series vaccination at 2, 3, and 4 months of age.

    Reporting group values
    PEDIACEL Infanrix-IPV+Hib Total
    Number of subjects
    292 292 584
    Age categorical
    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)
    292 292 584
        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)
    2.2 ± 0.17 2.1 ± 0.16 -
    Gender categorical
    Units: Subjects
        Female
    138 139 277
        Male
    154 153 307
    Subject analysis sets

    Subject analysis set title
    PEDIACEL (Booster)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Infants received PEDIACEL co-administered with Prevenar as a booster vaccination at 12 to 18 months of age.

    Subject analysis set title
    Infanrix-IPV+Hib (Booster)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Infants received Infanrix-IPV+Hib coadministered with Prevenar a booster vaccination at 12 to 18 months of age.

    Subject analysis sets values
    PEDIACEL (Booster) Infanrix-IPV+Hib (Booster)
    Number of subjects
    267
    263
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    267
    263
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    13.8 ± 1.61
    13.9 ± 1.53
    Gender categorical
    Units: Subjects
        Female
    126
    123
        Male
    141
    140

    End points

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    End points reporting groups
    Reporting group title
    PEDIACEL
    Reporting group description
    Infants received PEDIACEL co-administered with Prevenar as a primary series vaccination at 2, 3, and 4 months of age.

    Reporting group title
    Infanrix-IPV+Hib
    Reporting group description
    Infants received Infanrix-IPV+Hib coadministered with Prevenar as a primary series vaccination at 2, 3, and 4 months of age.
    Reporting group title
    PEDIACEL
    Reporting group description
    Infants received PEDIACEL co-administered with Prevenar as dose 4 booster at 12-18 months of age.

    Reporting group title
    Infanrix-IPV+Hib
    Reporting group description
    Infants received Infanrix-IPV+Hib coadministered with Prevenar as dose 4 booster at 12-18 months of age.

    Subject analysis set title
    PEDIACEL (Booster)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Infants received PEDIACEL co-administered with Prevenar as a booster vaccination at 12 to 18 months of age.

    Subject analysis set title
    Infanrix-IPV+Hib (Booster)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Infants received Infanrix-IPV+Hib coadministered with Prevenar a booster vaccination at 12 to 18 months of age.

    Primary: Seroprotection Against Purified Polyribosylribitol Phosphate Capsular Polysaccharide, Diphtheria, Tetanus, Polio, and Pneumococcal Serotypes Antigens After Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine with Prevenar

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    End point title
    Seroprotection Against Purified Polyribosylribitol Phosphate Capsular Polysaccharide, Diphtheria, Tetanus, Polio, and Pneumococcal Serotypes Antigens After Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine with Prevenar
    End point description
    Polyribosylribitol Phosphate (PRP) antibodies were assessed by radioimmunoassay. Diphtheria and poliovirus antibodies were assessed by serum neutralization assay. Tetanus and pneumococcal antigens antibodies were assessed by enzyme-linked immunosorbent assay. Seroprotection was defined as ≥ 0.15 µg/mL for PRP, ≥ 0.1 IU/mL for diphtheria and tetanus, ≥ 1:8 (dil) for poliovirus types 1, 2, and 3, and ≥ 0.35 µg/mL for pneumoccocal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).
    End point type
    Primary
    End point timeframe
    Post-dose 3 vaccination
    End point values
    PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    248
    242
    Units: Percentage of subjects
    number (not applicable)
        PRP
    91
    80.8
        Diphtheria toxoid
    99.2
    100
        Tetanus toxoid
    100
    100
        Polio 1
    100
    100
        Polio 2
    99.2
    100
        Polio 3
    99.6
    100
        Pneumo 4
    99.6
    100
        Pneumo 6B
    84.4
    84.6
        Pneumo 9V
    97.9
    98.7
        Pneumo 14
    99.2
    100
        Pneumo 18C
    97.5
    96.6
        Pneumo 19F
    100
    100
        Pneumo 23F
    90.5
    91.5
    Statistical analysis title
    PRP; Difference in PEDIACEL - Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for PRP antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    10.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.1
         upper limit
    16.5
    Notes
    [1] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Diphtheria;Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Diphtheria toxoid antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.9
         upper limit
    0.9
    Notes
    [2] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Tetanus; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Tetanus toxoid antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.5
         upper limit
    1.6
    Notes
    [3] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Polio 1; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Poliovirus type 1 antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [4]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.6
         upper limit
    1.6
    Notes
    [4] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Polio 2; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Poliovirus type 2 antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [5]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    0.9
    Notes
    [5] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Polio 3; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Poliovirus type 3 antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [6]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    1.2
    Notes
    [6] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 4; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 4 antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [7]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    1.2
    Notes
    [7] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 6B; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 6B antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [8]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.8
         upper limit
    6.3
    Notes
    [8] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 9V; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 9V antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [9]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.6
         upper limit
    1.9
    Notes
    [9] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 14; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 14 antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [10]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    0.9
    Notes
    [10] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 18C;Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 18C antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [11]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    4.4
    Notes
    [11] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 19F;Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 19F antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [12]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.6
         upper limit
    1.6
    Notes
    [12] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 23F;Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 23F antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [13]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.2
         upper limit
    4.3
    Notes
    [13] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.

    Primary: Summary of Seroresponse Against Pertussis Antigens Post-dose 3 Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV + Hib Vaccine Co-administered with Prevenar

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    End point title
    Summary of Seroresponse Against Pertussis Antigens Post-dose 3 Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV + Hib Vaccine Co-administered with Prevenar [14]
    End point description
    Pertussis antigen antibodies (Pertussis toxoid [PT], Filamentous haemagglutinin [FHA], Pertactin, and fimbriae) were assessed using enzyme-linked immunosorbent assay. Seroresponse for PT, Pertactin, and Fimbriae types 2 and 3 (Fimbriae) 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. Seroresponse for FHA 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
    Post-dose 3 vaccination
    Notes
    [14] - 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 study vaccines administered for this outcome.
    End point values
    PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    248
    242
    Units: Percentage of subjects
    number (not applicable)
        Pertussis toxoid
    98.7
    99.6
        Filamentous haemagglutinin
    93.2
    97.4
        Pertactin
    87.5
    93.5
        Fimbriae
    95.8
    4
    No statistical analyses for this end point

    Secondary: Summary of Geometric Mean Titers of Antibodies to PRP, Diphtheria, Tetanus, Polio and Pneumococcal Serotypes Antigens Post-dose 3 Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine Co-administered with Prevenar

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    End point title
    Summary of Geometric Mean Titers of Antibodies to PRP, Diphtheria, Tetanus, Polio and Pneumococcal Serotypes Antigens Post-dose 3 Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine Co-administered with Prevenar
    End point description
    Polyribosylribitol Phosphate (PRP) antibodies were assessed by radioimmunoassay. Diphtheria and poliovirus antibodies were assessed by serum neutralization assay. Tetanus and pneumococcal antigens antibodies were assessed by enzyme-linked immunosorbent assay.
    End point type
    Secondary
    End point timeframe
    Post-Dose 3 vaccination
    End point values
    PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    248
    242
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        PRP
    1.38 (1.14 to 1.66)
    0.59 (0.49 to 0.71)
        Diphtheria
    0.09 (0.07 to 0.1)
    0.07 (0.06 to 0.08)
        Tetanus
    0.68 (0.62 to 0.75)
    0.74 (0.68 to 0.81)
        Polio 1
    238.71 (200.2 to 284.62)
    340.2 (281.96 to 410.47)
        Polio 2
    266.31 (216.11 to 328.18)
    333.1 (272.04 to 407.88)
        Polio 3
    406.18 (334.32 to 493.48)
    590.95 (484.13 to 721.33)
        Pneumo 4
    2.96 (2.7 to 3.25)
    3.09 (2.82 to 3.4)
        Pneumo 6B
    1.01 (0.88 to 1.15)
    1.07 (0.93 to 1.24)
        Pneumo 9V
    2.01 (1.82 to 2.21)
    2.35 (2.13 to 2.6)
        Pneumo 14
    9.42 (8.3 to 10.68)
    8.38 (7.29 to 9.64)
        Pneumo 18C
    2.01 (1.82 to 2.22)
    2.07 (1.86 to 2.31)
        Pneumo 19F
    4.14 (3.8 to 4.51)
    4.36 (4.01 to 4.73)
        Pneumo 23F
    1.48 (1.29 to 1.68)
    1.54 (1.34 to 1.77)
    No statistical analyses for this end point

    Secondary: Summary of Geometric Mean Titers (GMTs) of Antibodies to Pertussis Antigens Before and Following a 3-Dose Primary Series Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine Co-administered with Prevenar

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    End point title
    Summary of Geometric Mean Titers (GMTs) of Antibodies to Pertussis Antigens Before and Following a 3-Dose Primary Series Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine Co-administered with Prevenar
    End point description
    Pneumococcal antigens (Pertussis toxoid, Filamentous haemagglutinin [FHA], Pertactin, and Fimbriae types 2 and 3 [Fimbriae]) antibodies were assessed by enzyme-linked immunosorbent assay.
    End point type
    Secondary
    End point timeframe
    Pre-Dose 1 and Post-Dose 3 vaccination
    End point values
    PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    248
    242
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Pertussis toxoid; Pre-dose 1
    4.18 (3.74 to 4.68)
    3.79 (3.37 to 4.25)
        Pertussis toxoid; Post-dose 3
    109.58 (100.95 to 118.96)
    76.69 (71.01 to 82.82)
        Filamentous Haemagglutinin; Pre-dose 1
    6.07 (5.41 to 6.82)
    5.3 (4.67 to 6.01)
        Filamentous Haemagglutinin; Post-dose 3
    40.1 (36.7 to 43.82)
    70.22 (65.08 to 75.77)
        Pertactin; Pre-dose 1
    3.78 (3.36 to 4.24)
    3.6 (3.23 to 4.03)
        Pertactin; Post-dose 3
    33.31 (29.28 to 37.91)
    64.08 (57.12 to 71.89)
        Fimbriae; Pre-dose 1
    10.41 (8.93 to 12.14)
    12.15 (10.29 to 14.35)
        Fimbriae; Post-dose 3
    206.94 (183.56 to 233.3)
    3.77 (3.3 to 4.31)
    No statistical analyses for this end point

    Secondary: Summary of Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens Before and Following a Booster Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine Co-administered with Prevenar

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    End point title
    Summary of Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens Before and Following a Booster Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine Co-administered with Prevenar
    End point description
    Polyribosylribitol Phosphate (PRP) antibodies were assessed by radioimmunoassay. Diphtheria and poliovirus antibodies were assessed by serum neutralization assay. Tetanus and pneumococcal antigens antibodies were assessed by enzyme-linked immunosorbent assay.
    End point type
    Secondary
    End point timeframe
    Pre- and Post-Booster 4 vaccination
    End point values
    PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    220
    207
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        PRP; Pre-dose 4
    0.36 (0.29 to 0.45)
    0.14 (0.12 to 0.17)
        PRP; Post-dose 4
    32.41 (27.35 to 38.39)
    19.26 (15.77 to 23.54)
        Diphtheria; Pre-dose 4
    0.13 (0.11 to 0.16)
    0.11 (0.09 to 0.13)
        Diphtheria; Post-dose 4
    4.72 (4.15 to 5.36)
    3.83 (3.38 to 4.34)
        Tetanus; Pre-dose 4
    0.17 (0.14 to 0.2)
    0.13 (0.11 to 0.16)
        Tetanus; Post-dose 4
    3.03 (2.7 to 3.4)
    2.77 (2.49 to 3.1)
        Pertussis toxoid; Pre-dose 4
    16.14 (14.48 to 18)
    11.6 (10.31 to 13.04)
        Pertussis toxoid; Post-dose 4
    174.68 (157.78 to 193.39)
    110.43 (100 to 121.94)
        Filamentous haemagglutinin; Pre-dose 4
    12.44 (11 to 14.07)
    16.56 (14.62 to 18.76)
        Filamentous haemagglutinin; Post-dose 4
    70.3 (63.1 to 78.31)
    161.68 (146.75 to 178.13)
        Pertactin; Pre-dose 4
    5.2 (4.54 to 5.95)
    7.42 (6.41 to 8.58)
        Pertactin; Post-dose 4
    79.59 (69.27 to 91.44)
    177.82 (155.88 to 202.84)
        Fimbriae; Pre-dose 4
    39.87 (34.65 to 45.89)
    2.08 (2.01 to 2.16)
        Fimbriae; Post-dose 4
    494.88 (435.45 to 562.42)
    2.64 (2.33 to 2.99)
        Polio 1; Pre-dose 4
    68.99 (55.45 to 85.84)
    93.81 (75.26 to 116.93)
        Polio 1; Post-dose 4
    2984.82 (2514.77 to 3542.73)
    4554.02 (3817.41 to 5432.76)
        Polio 2; Pre-dose 4
    87.8 (71.48 to 107.85)
    89.58 (71.88 to 111.64)
        Polio 2; Post-dose 4
    4220.46 (3573.91 to 4983.96)
    5238.99 (4373.66 to 6275.52)
        Polio 3; Pre-dose 4
    74.98 (59.95 to 93.77)
    101.26 (82.17 to 124.79)
        Polio 3; Post-dose 4
    4200.53 (3417.67 to 5162.71)
    5870.72 (4875.47 to 7069.15)
        Pneumo 4; Pre-dose 4
    0.42 (0.37 to 0.47)
    0.43 (0.38 to 0.48)
        Pneumo 4; Post-dose 4
    5.46 (4.83 to 6.17)
    5.87 (5.16 to 6.67)
        Pneumo 6B; Pre-dose 4
    0.42 (0.36 to 0.49)
    0.44 (0.37 to 0.51)
        Pneumo 6B; Post-dose 4
    8.51 (7.4 to 9.78)
    8.43 (7.28 to 9.76)
        Pneumo 9V; Pre-dose 4
    0.39 (0.35 to 0.44)
    0.42 (0.37 to 0.48)
        Pneumo 9V; Post-dose 4
    4.47 (4.01 to 4.99)
    5.07 (4.5 to 5.72)
        Pneumo 14; Pre-dose 4
    2.45 (2.14 to 2.8)
    2.41 (2.07 to 2.8)
        Pneumo 14; Post-dose 4
    17.54 (15.55 to 19.8)
    18.33 (16.15 to 20.79)
        Pneumo 18C; Pre-dose 4
    0.25 (0.23 to 0.28)
    0.27 (0.24 to 0.31)
        Pneumo 18C; Post-dose 4
    2.37 (2.11 to 2.66)
    2.89 (2.55 to 3.27)
        Pneumo 19F; Pre-dose 4
    0.88 (0.75 to 1.03)
    0.85 (0.72 to 1)
        Pneumo 19F; Post-dose 4
    5.86 (5.23 to 6.58)
    6.9 (6.18 to 7.71)
        Pneumo 23F; Pre-dose 4
    0.38 (0.33 to 0.44)
    0.37 (0.32 to 0.43)
        Pneumo 23F; Post-dose 4
    5.17 (4.51 to 5.92)
    5.73 (4.96 to 6.61)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Booster Response Against Pertussis Antigens Before and Following Booster Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV + Hib Vaccine Co-administered with Prevenar

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    End point title
    Percentage of Subjects with Booster Response Against Pertussis Antigens Before and Following Booster Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV + Hib Vaccine Co-administered with Prevenar
    End point description
    Pneumococcal antigens (Pertussis toxoid [PT], Filamentous haemagglutinin [FHA], Pertactin, Fimbriae types 2 and 3) antibodies were assessed by enzyme-linked immunosorbent assay. Seroresponse for the pertussis antigens was defined as < 4X lower limit of quantitation (LLOQ) and ≥ 4XLLOQ. Booster response was defined as four fold-rise from pre-Dose 4, if pre-Dose 4 < 4XLLOQ or two fold-rise from pre-Dose 4 if pre-Dose 4 ≥ 4XLLOQ.
    End point type
    Secondary
    End point timeframe
    Pre- and Post-dose 4 vaccination
    End point values
    PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    220
    207
    Units: Percentage of subjects
    number (not applicable)
        Pertussis toxoid; < 4XLLOQ; Pre-dose 4
    46.5
    60
        Pertussis toxoid; ≥ 4XLLOQ; Pre-dose 4
    53.5
    40
        Pertussis toxoid; Booster response; Post-dose 4
    96.7
    95
        FHA; < 4XLLOQ; Pre-dose 4
    47.4
    32.3
        FHA; ≥ 4XLLOQ; Pre-dose 4
    52.6
    67.7
        FHA; Booster response; Post-dose 4
    83.2
    96
        Pertactin; < 4XLLOQ; Pre-dose 4
    87
    74.6
        Pertactin; ≥ 4XLLOQ; Pre-dose 4
    13
    25.4
        Pertactin; Booster response; Post-dose 4
    86.9
    98
        Fimbriae; < 4XLLOQ; Pre-dose 4
    11.7
    99.5
        Fimbriae; ≥ 4XLLOQ; Pre-dose 4
    88.3
    0.5
        Fimbriae; Booster response; Post-dose 4
    95.7
    5.1
    No statistical analyses for this end point

    Secondary: Seroprotection Against Purified Polyribosylribitol Phosphate Capsular Polysaccharide, Diphtheria, Tetanus, Polio, and Pneumococcal Serotypes Antigens After a Booster With PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine With Prevenar

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    End point title
    Seroprotection Against Purified Polyribosylribitol Phosphate Capsular Polysaccharide, Diphtheria, Tetanus, Polio, and Pneumococcal Serotypes Antigens After a Booster With PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine With Prevenar
    End point description
    Polyribosylribitol Phosphate (PRP) antibodies were assessed by radioimmunoassay. Diphtheria toxoid and poliovirus antibodies were assessed by serum neutralization assay. Tetanus toxoid and pneumococcal antigens antibodies were assessed by enzyme-linked immunosorbent assay. Seroprotection was defined as ≥ 1.0 µg/mL for PRP, ≥ 0.1 IU/mL for diphtheria and tetanus, ≥ 1:8 (dil) for poliovirus types 1, 2, and 3, and ≥ 0.35 µg/mL for pneumoccocal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F). Data show percentage of subjects with seroprotection against each vaccine antigen.
    End point type
    Secondary
    End point timeframe
    Post-dose 4 vaccination
    End point values
    PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    220
    207
    Units: Percentage of subjects
    number (not applicable)
        PRP
    99.1
    95.2
        Diphtheria
    99.1
    100
        Tetanus
    100
    100
        Polio 1
    99.5
    100
        Polio 2
    99.5
    100
        Polio 3
    99.5
    100
        Pneumo 4
    99.5
    100
        Pneumo 6B
    99.5
    99.5
        Pneumo 9V
    99.5
    100
        Pneumo 14
    100
    100
        Pneumo 18C
    99.1
    100
        Pneumo 19F
    99.5
    100
        Pneumo 23F
    99.1
    99
    Statistical analysis title
    PRP; Difference in PEDIACEL - Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for PRP antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [15]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    3.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    7.8
    Notes
    [15] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Diphtheria;Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Diphtheria antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [16]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.3
         upper limit
    1
    Notes
    [16] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Tetanus; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Tetanus antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [17]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    1.8
    Notes
    [17] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Polio 1; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Polio 1 antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [18]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    1.4
    Notes
    [18] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Polio 2; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Polio 2 antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [19]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    1.4
    Notes
    [19] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Polio 3; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Polio 3 antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [20]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    1.4
    Notes
    [20] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 4; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 4 antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [21]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.6
         upper limit
    1.4
    Notes
    [21] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 6B; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 6B antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [22]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.1
         upper limit
    2.3
    Notes
    [22] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 9V; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 9V antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [23]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.6
         upper limit
    1.4
    Notes
    [23] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 14; Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 14 antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [24]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    1.9
    Notes
    [24] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 18C;Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 18C antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [25]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.3
         upper limit
    1
    Notes
    [25] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 19F;Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 19F antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [26]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.6
         upper limit
    1.4
    Notes
    [26] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.
    Statistical analysis title
    Pneumo 23F;Difference in PEDIACEL-Infanrix-IPV+Hib
    Statistical analysis description
    Difference in seroprotection rates in PEDIACEL and Infanrix-IPV+Hib for Pneumo 23F antigen.
    Comparison groups
    PEDIACEL v Infanrix-IPV+Hib
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [27]
    Method
    Parameter type
    Difference in PEDIACEL-Infanrix-IPV+Hib
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.4
         upper limit
    2.7
    Notes
    [27] - The difference in the seroprotection rate was defined as PEDIACEL seroprotection rate minus Infanrix-IPV+Hib seroprotection rate. Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval of PEDIACEL - Infanrix-IPV+Hib is >-10% for PRP and pneumococcal serotypes and >-5% for diphtheria, tetanus and polio. The confidence intervals were computed using the Wilson score method without continuity correction. PEDIACEL was non-inferior to Infanrix-IPV+Hib.

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

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    End point title
    Percentage of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Any Primary Series Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine Co-administered with Prevenar
    End point description
    Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-primary series vaccination
    End point values
    PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    292
    292
    Units: Percentage of subjects
    number (not applicable)
        Injection site Tenderness
    61.2
    63.1
        Injection site Erythema
    66.7
    66.9
        Injection site Swelling
    51.5
    47.2
        Fever
    51.5
    50.7
        Vomiting
    28.2
    26.6
        Crying abnormal
    59.1
    57.6
        Drowsiness
    54.3
    59
        Appetite lost
    47.1
    45.2
        Irritability
    69.4
    68.3
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Each Primary Series Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine Co-administered with Prevenar
    End point description
    Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥ 5 cm. Grade 3 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 lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability, Inconsolable.
    End point type
    Secondary
    End point timeframe
    Post-dose 1 (2 months), post-dose 2 (3 months), and post-dose 3 (4 months)
    End point values
    PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    292
    292
    Units: Percentage of subjects
    number (not applicable)
        Any Inj. site Tenderness; Post-dose 1 (2 months)
    45
    45
        Grade 3 Inj. site Tenderness; Post-dose 1 (2 mths)
    4.1
    1.7
        Any Inj. site Tenderness; Post-dose 2 (3 months)
    37.8
    38.3
        Grade 3 Inj. site Tenderness; Post-dose 2 (3 mths)
    1
    0
        Any Inj. site Tenderness; Post-dose 3 (4 months)
    33
    33.1
        Grade 3 Inj. site Tenderness; Post-dose 3 (4 mths)
    0.3
    0.4
        Any Inj. site Erythema; Post-dose 1 (2 months)
    38.5
    40.8
        Grade 3 Inj. site Erythema; Post-dose 1 (2 months)
    1.7
    0.7
        Any Inj. site Erythema; Post-dose 2 (3 months)
    46.9
    47.4
        Grade 3 Inj. site Erythema; Post-dose 2 (3 months)
    1
    0
        Any Inj. site Erythema; Post-dose 3 (4 months)
    46.2
    47.3
        Grade 3 Inj. site Erythema; Post-dose 3 (4 months)
    0.7
    0.4
        Any Inj. site Swelling; Post-dose 1 (2 months)
    26.8
    27.4
        Grade 3 Inj. site Swelling; Post-dose 1 (2 months)
    1
    0
        Any Inj. site Swelling; Post-dose 2 (3 months)
    29.9
    33.9
        Grade 3 Inj. site Swelling; Post-dose 2 (3 months)
    1
    0
        Any Inj. site Swelling; Post-dose 3 (4 months)
    38.2
    32.4
        Grade 3 Inj. site Swelling; Post-dose 3 (4 months)
    0.7
    0
        Any Fever; Post-dose 1 (2 months)
    21
    24
        Grade 3 Fever; Post-dose 1 (2 months)
    0
    0.3
        Any Fever; Post-dose 2 (3 months)
    29.5
    30.5
        Grade 3 Fever; Post-dose 2 (3 months)
    0
    0
        Any Fever; Post-dose 3 (4 months)
    26.8
    28.6
        Grade 3 Fever; Post-dose 3 (4 months)
    0
    0.7
        Any Vomiting; Post-dose 1 (2 months)
    17.5
    14.5
        Grade 3 Vomiting; Post-dose 1 (2 months)
    1
    0
        Any Vomiting; Post-dose 2 (3 months)
    12.5
    11.5
        Grade 3 Vomiting; Post-dose 2 (3 months)
    0.3
    0.3
        Any Vomiting; Post-dose 3 (4 months)
    11.8
    8.9
        Grade 3 Vomiting; Post-dose 3 (4 months)
    0.7
    0
        Any Crying abnormal; Post-dose 1 (2 months)
    45
    41.4
        Grade 3 Crying abnormal; Post-dose 1 (2 months)
    2.4
    1
        Any Crying abnormal; Post-dose 2 (3 months)
    34.6
    36.2
        Grade 3 Crying abnormal; Post-dose 2 (3 months)
    1
    2.4
        Any Crying abnormal; Post-dose 3 (4 months)
    29.5
    26.7
        Grade 3 Crying abnormal; Post-dose 3 (4 months)
    2.4
    1.8
        Any Drowsiness; Post-dose 1 (2 months)
    41.2
    39
        Grade 3 Drowsiness; Post-dose 1 (2 months)
    4.5
    2.8
        Any Drowsiness; Post-dose 2 (3 months)
    32.9
    38
        Grade 3 Drowsiness; Post-dose 2 (3 months)
    0
    0.7
        Any Drowsiness; Post-dose 3 (4 months)
    24.7
    26.7
        Grade 3 Drowsiness; Post-dose 3 (4 months)
    1.4
    1.1
        Any Appetite lost; Post-dose 1 (2 months)
    26.8
    26.9
        Grade 3 Appetite lost; Post-dose 1 (2 months)
    0.3
    0
        Any Appetite lost; Post-dose 2 (3 months)
    22.8
    28.2
        Grade 3 Appetite lost; Post-dose 2 (3 months)
    0.3
    1
        Any Appetite lost; Post-dose 3 (4 months)
    25
    22.1
        Grade 3 Appetite lost; Post-dose 3 (4 months)
    0
    0.7
        Any Irritability; Post-dose 1 (2 months)
    53.3
    50.3
        Grade 3 Irritability; Post-dose 1 (2 months)
    5.2
    3.4
        Any Irritability; Post-dose 2 (3 months)
    48.1
    48.8
        Grade 3 Irritability; Post-dose 2 (3 months)
    1.7
    3.8
        Any Irritability; Post-dose 3 (4 months)
    42
    35.6
        Grade 3 Irritability; Post-dose 3 (4 months)
    2.4
    1.4
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination with Either PEDIACEL Co-administered with Prevenar or Infanrix-IPV+Hib Vaccine Co-administered with Prevenar
    End point description
    Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥ 5 cm. Grade 3 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 lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability, Inconsolable.
    End point type
    Secondary
    End point timeframe
    Post-dose 4 vaccination
    End point values
    PEDIACEL Infanrix-IPV+Hib
    Number of subjects analysed
    267
    264
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Tenderness
    56.9
    63.5
        Grade 3 Injection site Tenderness
    2.6
    2.7
        Any Injection site Erythema
    55.8
    58.9
        Grade 3 Injection site Erythema
    2.2
    3
        Any Injection site Swelling
    29.2
    40.3
        Grade 3 Injection site Swelling
    1.5
    0.8
        Any Fever
    48.3
    52.9
        Grade 3 Fever
    1.5
    3
        Any Vomiting
    4.9
    8.7
        Grade 3 Vomiting
    0
    0
        Any Crying abnormal
    32.2
    34.2
        Grade 3 Crying abnormal
    0.4
    0.4
        Any Drowsiness
    30.3
    32.7
        Grade 3 Drowsiness
    0
    0
        Any Appetite lost
    33.7
    35.4
        Grade 3 Appetite lost
    0.4
    1.5
        Any Irritability
    52.1
    53.2
        Grade 3 Irritability
    0.7
    1.1
    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 up to Day 7 post-dose 4 vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    PEDIACEL (Primary and Booster)
    Reporting group description
    Infants received PEDIACEL co-administered with Prevenar as a primary series vaccination at 2, 3, and 4 months of age and as a booster at 12 to 18 months of age.

    Reporting group title
    Infanrix-IPV+Hib (Primary and Booster)
    Reporting group description
    Infants received Infanrix-IPV+Hib coadministered with Prevenar as a primary series vaccination at 2, 3, and 4 months of age and as a booster vaccination at 12 to 18 months of age.

    Serious adverse events
    PEDIACEL (Primary and Booster) Infanrix-IPV+Hib (Primary and Booster)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 292 (8.56%)
    22 / 292 (7.53%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Chemical poisoning
         subjects affected / exposed
    1 / 292 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 292 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 292 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Circumcision
         subjects affected / exposed
    1 / 292 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood immunoglobulin A decreased
         subjects affected / exposed
    0 / 292 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Immunodeficiency
         subjects affected / exposed
    1 / 292 (0.34%)
    0 / 292 (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
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 292 (0.00%)
    1 / 292 (0.34%)
         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
    1 / 292 (0.34%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nystagmus
         subjects affected / exposed
    1 / 292 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope vasovagal
         subjects affected / exposed
    0 / 292 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 292 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroesophageal reflux disease
         subjects affected / exposed
    0 / 292 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 292 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatosplenomegaly
         subjects affected / exposed
    0 / 292 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 292 (0.34%)
    0 / 292 (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
    Bronchiolitis
         subjects affected / exposed
    4 / 292 (1.37%)
    6 / 292 (2.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    5 / 292 (1.71%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis acute
         subjects affected / exposed
    2 / 292 (0.68%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 292 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 292 (0.68%)
    3 / 292 (1.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 292 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 292 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perianal abscess
         subjects affected / exposed
    1 / 292 (0.34%)
    0 / 292 (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
    0 / 292 (0.00%)
    2 / 292 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 292 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Roseola
         subjects affected / exposed
    1 / 292 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 292 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 292 (0.68%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral rash
         subjects affected / exposed
    1 / 292 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    PEDIACEL (Primary and Booster) Infanrix-IPV+Hib (Primary and Booster)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    202 / 292 (69.18%)
    198 / 292 (67.81%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    158 / 292 (54.11%)
    171 / 292 (58.56%)
         occurrences all number
    158
    171
    General disorders and administration site conditions
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    178 / 292 (60.96%)
    167 / 292 (57.19%)
         occurrences all number
    178
    167
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    194 / 292 (66.44%)
    194 / 292 (66.44%)
         occurrences all number
    194
    194
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    150 / 292 (51.37%)
    137 / 292 (46.92%)
         occurrences all number
    150
    137
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    150 / 292 (51.37%)
    142 / 292 (48.63%)
         occurrences all number
    150
    142
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    172 / 292 (58.90%)
    167 / 292 (57.19%)
         occurrences all number
    172
    167
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    202 / 292 (69.18%)
    198 / 292 (67.81%)
         occurrences all number
    202
    198
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    82 / 292 (28.08%)
    77 / 292 (26.37%)
         occurrences all number
    82
    77
    Metabolism and nutrition disorders
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed
    137 / 292 (46.92%)
    131 / 292 (44.86%)
         occurrences all number
    137
    131

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2006
    The new location of the PRP antibody testing and the list of investigators were updated.
    04 Dec 2007
    The new location of the Polio antibody testing was updated; the precision of the Restricted Concomitant Therapy Category 2 definition was increased to reflect the timing of the blood draw for the immunogenicity assessment; the definition of fever was updated; the temperature conditions for the storage of serum were clarified, and the Clinical Trial Leader was updated in the List of Investigators.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/21807056
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