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    Clinical Trial Results:
    Safety and Immunogenicity of Booster Vaccination with PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Booster Vaccination with Infanrix® hexa when Both Vaccines Are Co-Administered with Prevenar® to Toddlers 11-18 Months of Age

    Summary
    EudraCT number
    		 2006-000898-30
    Trial protocol
    		 DE  
    Global end of trial date
    17 Sep 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Feb 2016
    First version publication date
    30 Jan 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A5I19
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00355654
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    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?
    No
    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
    28 Jul 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of PEDIACEL® booster dose by comparing the fever rates between PEDIACEL® and Infanrix® hexa vaccines when both are co-administered with Prevenar® to toddlers at 11-18 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
    		 Not applicable
    Evidence for comparator
    		 The control, Infanrix® hexa, is a licensed combination vaccine.
    Actual start date of recruitment
    29 Sep 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
    Germany: 847
    Worldwide total number of subjects
    847
    EEA total number of subjects
    847
    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)
    847
    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 29 September 2006 to 29 June 2007 at 53 clinical centers in Germany.

    Pre-assignment
    Screening details
    		 A total of 847 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled; 845 were vaccinated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    Subjects and assessors were blinded to the vaccine. Each site had 1 designated person who was unblinded to the randomisation/vaccine administered and was responsible for the preparation and administration of the vaccine. All others remained blinded to the vaccine group until after the safety assessment. Before the assessment, the code was broken if it was necessary to determine/influence treatment of serious AEs. It was also broken afterwards for Pediacel subjects to receive ENGERIX-B Kinder.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PEDIACEL
    Arm description
    		 Subjects who received PEDIACEL (0.5 mL) as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months followed by ENGERIX-B Kinder (0.5 mL) 1 month later, at 12 to 19 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PEDIACEL
    Investigational medicinal product code
    HCPDT-IPV-PRP-T
    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, one dose at 11-18 months of age.

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Pneumococcal saccharide conjugated vaccine, adsorb
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the deltoid muscle, one dose at 11-18 months of age.

    Investigational medicinal product name
    ENGERIX-B Kinder
    Investigational medicinal product code
    Hepatitis B recombinant vaccine, adsorbed
    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, one dose at 12-19 months of age.

    Arm title
    		 Infanrix hexa
    Arm description
    		 Subjects who received Infanrix hexa as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    DTPa-HBV-IPV+Hib
    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, one dose at 11-18 months of age.

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Pneumococcal saccharide conjugated vaccine, adsorb
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the deltoid muscle, one dose at 11-18 months of age.

    Number of subjects in period 1
    		PEDIACEL Infanrix hexa
    Started
    423
    424
    Completed
    420
    417
    Not completed
    3
    7
         Consent withdrawn by subject
    1
    2
         Lost to follow-up
    1
    3
         Protocol deviation
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PEDIACEL
    Reporting group description
    		 Subjects who received PEDIACEL (0.5 mL) as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months followed by ENGERIX-B Kinder (0.5 mL) 1 month later, at 12 to 19 months.

    Reporting group title
    Infanrix hexa
    Reporting group description
    		 Subjects who received Infanrix hexa as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months.

    Reporting group values
    		 PEDIACEL Infanrix hexa Total
    Number of subjects
    		 423 424 847
    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)
    		 423 424 847
        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)
    		 14 ( 1.9 ) 14.1 ( 1.91 ) -
    Gender categorical
    Units: Subjects
        Female
    		 176 207 383
        Male
    		 247 217 464

    End points

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    End points reporting groups
    Reporting group title
    PEDIACEL
    Reporting group description
    		 Subjects who received PEDIACEL (0.5 mL) as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months followed by ENGERIX-B Kinder (0.5 mL) 1 month later, at 12 to 19 months.

    Reporting group title
    Infanrix hexa
    Reporting group description
    		 Subjects who received Infanrix hexa as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months.

    Primary: Number of Subjects Reporting Fever Within Four Days of Booster Vaccination With Either PEDIACEL or Infanrix Hexa Vaccine

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    End point title
    		 Number of Subjects Reporting Fever Within Four Days of Booster Vaccination With Either PEDIACEL or Infanrix Hexa Vaccine
    End point description
    Fever was defined as a temperature ≥ 38.0°C.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 4 post-vaccination
    End point values
    		 PEDIACEL Infanrix hexa
    Number of subjects analysed
    422
    421
    Units: Subjects
    number (not applicable)
        Fever (≥ 38.0°C)
    250
    262
    Statistical analysis title
    		 Non-Inferiority of PEDIACEL to Infanrix Hexa
    Statistical analysis description
    Non-Inferiority of PEDIACEL to Infanrix Hexa with respect to Fever rates (≥ 38.0°C) within 4 Days post-booster vaccination when both were co-administered with Prevenar.
    Comparison groups
    PEDIACEL v Infanrix hexa
    Number of subjects included in analysis
    843
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 3.4
    Notes
    [1] - Non-inferiority is achieved if the upper limit of the two-sided 95% CI of PEDIACEL - Infanrix hexa is < 10% (primary objective). Difference= PEDIACEL fever rate - Infanrix hexa fever rate. The CIs were computed using the normal approximation to the binomial distribution without continuity correction.

    Secondary: Number of Subjects Reporting Severe Fever Within Four Days Following Booster Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine

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    End point title
    		 Number of Subjects Reporting Severe Fever Within Four Days Following Booster Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine
    End point description
    Severe fever was defined as a temperature of ≥ 39.6°C.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 4 post-vaccination
    End point values
    		 PEDIACEL Infanrix hexa
    Number of subjects analysed
    422
    421
    Units: Subjects
    number (not applicable)
        Visit 1 (11 to 18 months)
    28
    17
        Visit 2 (12 to 19 months)
    10
    4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Seroprotection Against Vaccine Antigens Following Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine

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    End point title
    		 Percentage of Subjects With Seroprotection Against Vaccine Antigens Following Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine
    End point description
    Antibodies were measured by radioimmunoassay for polyribosylribitol phosphate (PRP); serum neutralization assay for diphtheria toxoid and poliovirus types 1, 2, and 3; and enzyme-linked immunosorbent assay for tetanus toxoid and all pneumococcal serotypes. Seroprotection was defined as titers of ≥1.0 µg/mL for PRP, ≥0.1 µg/mL for diphtheria toxoid and tetanus toxoid, ≥1:8 [1/dil] for poliovirus 1, 2, and 3, and ≥0.15 µg/mL for all pneumococcal serotypes.
    End point type
    Secondary
    End point timeframe
    1 month post-vaccination
    End point values
    		 PEDIACEL Infanrix hexa
    Number of subjects analysed
    79
    80
    Units: Percentage of subjects
    number (not applicable)
        PRP (≥1.00 µg/mL)
    100
    100
        Diphteria toxoid (≥ 0.1 IU/mL)
    100
    100
        Tetanus toxoid (≥ 0.1 IU/mL)
    100
    100
        Polio 1 (≥ 1:8 1/dil)
    100
    100
        Polio 2 (≥ 1:8 1/dil)
    100
    100
        Polio 3 (≥ 1:8 1/dil)
    100
    100
        Pneumo 4 (≥ 0.15 µg/mL)
    100
    100
        Pneumo 6B (≥ 0.15µg/mL)
    81.9
    82.4
        Pneumo 9V (≥ 0.15 µg/mL)
    97.4
    98.7
        Pneumo 14 (≥ 0.15 µg/mL)
    100
    100
        Pneumo 18C (≥ 0.15 µg/mL)
    98.7
    100
        Pneumo 19F (≥ 0.15 µg/mL)
    100
    100
        Pneumo 23F (≥ 0.15 µg/mL)
    75.7
    75
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens Before and Following Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens Before and Following Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine
    End point description
    Antibodies were measured by radioimmunoassay for polyribosylribitol phosphate (PRP); serum neutralization assay for diphtheria toxoid and poliovirus types 1, 2, and 3; enzyme-linked immunosorbent assay for tetanus toxoid, all pneumococcal (Pneumo 4, 6B, 9V, 14, 18C, 19F, 23F) serotypes, pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and 1 month post-vaccination
    End point values
    		 PEDIACEL Infanrix hexa
    Number of subjects analysed
    79
    80
    Units: Titers
    geometric mean (confidence interval 95%)
        PRP (Pre-Booster)
    0.44 (0.31 to 0.63)
    0.56 (0.4 to 0.78)
        PRP (Post-Booster)
    37.16 (27.8 to 49.67)
    30.27 (24.23 to 37.82)
        Diphtheria toxoid (Pre-Booster)
    0.06 (0.04 to 0.09)
    0.06 (0.04 to 0.08)
        Diphtheria toxoid (Post-Booster)
    2.72 (2.04 to 3.64)
    2.23 (1.71 to 2.9)
        Tetanus toxoid (Pre-Booster)
    0.39 (0.31 to 0.49)
    0.41 (0.33 to 0.5)
        Tetanus toxoid (Post-Booster)
    6.47 (5.25 to 7.97)
    4.67 (3.99 to 5.47)
        Polio 1 (Pre-Booster)
    230.86 (148.41 to 359.1)
    311.93 (209.67 to 464.05)
        Polio 1 (Post-Booster)
    5281.24 (3722.08 to 7493.52)
    6873.53 (5302.4 to 8910.19)
        Polio 2 (Pre-Booster)
    156.07 (98.8 to 246.55)
    235.26 (160.52 to 344.79)
        Polio 2 (Post-Booster)
    7791.2 (5634.91 to 10772.63)
    6596.57 (5110.91 to 8514.09)
        Polio 3 (Pre-Booster)
    339.96 (216.74 to 533.25)
    464.31 (326.34 to 660.61)
        Polio 3 (Post-Booster)
    8076.24 (5380.26 to 12123.16)
    10770.02 (8274.75 to 14017.75)
        PT (Pre-Booster)
    19.5 (15.7 to 24.22)
    17.99 (14.85 to 21.8)
        PT (Post-Booster)
    128.94 (105.7 to 157.28)
    126.8 (109.89 to 146.31)
        FHA (Pre-Booster)
    23.13 (18.31 to 29.23)
    24.65 (19.73 to 30.8)
        FHA (Post-Booster)
    125.53 (105.21 to 149.79)
    190.58 (166.15 to 218.59)
        PRN (Pre-Booster)
    20.02 (15.38 to 26.07)
    18.3 (13.79 to 24.28)
        PRN (Post-Booster)
    257.46 (205.63 to 322.35)
    324.3 (253.96 to 414.1)
        FIM (Pre-Booster)
    2.11 (1.98 to 2.26)
    2.18 (2.01 to 2.35)
        FIM (Post-Booster)
    6.61 (4.79 to 9.12)
    2.64 (2.22 to 3.13)
        Pneumo 4 (Pre-Booster)
    0.03 (0.02 to 0.04)
    0.04 (0.03 to 0.06)
        Pneumo 4 (Post-Booster)
    5.04 (4.01 to 6.34)
    4.41 (3.51 to 5.55)
        Pneumo 6B (Pre-Booster)
    0.1 (0.08 to 0.13)
    0.11 (0.08 to 0.14)
        Pneumo 6B (Post-Booster)
    0.66 (0.46 to 0.95)
    0.56 (0.41 to 0.77)
        Pneumo 9V (Pre-Booster)
    0.04 (0.03 to 0.05)
    0.04 (0.03 to 0.05)
        Pneumo 9V (Post-Booster)
    3.48 (2.62 to 4.62)
    3.27 (2.65 to 4.03)
        Pneumo 14 (Pre-Booster)
    0.08 (0.06 to 0.12)
    0.1 (0.07 to 0.15)
        Pneumo 14 (Post-Booster)
    4.35 (3.5 to 5.4)
    4.85 (3.87 to 6.07)
        Pneumo 18C (Pre-Booster)
    0.02 (0.01 to 0.03)
    0.02 (0.01 to 0.03)
        Pneumo 18C (Post-Booster)
    3.57 (2.92 to 4.37)
    3.89 (3.26 to 4.63)
        Pneumo 19F (Pre-Booster)
    0.52 (0.41 to 0.65)
    0.63 (0.49 to 0.81)
        Pneumo 19F (Post-Booster)
    1.72 (1.4 to 2.11)
    1.86 (1.54 to 2.25)
        Pneumo 23F (Pre-Booster)
    0.04 (0.03 to 0.06)
    0.04 (0.03 to 0.06)
        Pneumo 23F (Post-Booster)
    0.51 (0.36 to 0.73)
    0.46 (0.33 to 0.65)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Booster Response for Pertussis Antigens Post- Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine

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    End point title
    		 Percentage of Subjects with Booster Response for Pertussis Antigens Post- Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine
    End point description
    Antibodies were measured using an enzyme-linked immunosorbent assay for pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM). Booster response was defined as ≥ 4-fold rise from baseline if baseline antibody response was < 4x lower limit of quantification (LLOQ) or ≥ 2-fold rise from baseline if baseline antibody response was ≥ 4xLLOQ.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) to 1 month post-vaccination
    End point values
    		 PEDIACEL Infanrix hexa
    Number of subjects analysed
    79
    80
    Units: Percentage of subjects
    number (not applicable)
        PT
    90.4
    92.1
        FHA
    86.7
    94.7
        PRN
    95.9
    96.1
        FIM
    26.4
    5.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Seroprotection Against Hepatitis B Antigens Following Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine

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    End point title
    		 Percentage of Subjects with Seroprotection Against Hepatitis B Antigens Following Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine
    End point description
    Anti-Hepatitis B antibodies were measured using enhanced chemiluminescence [ECi]). Seroprotection was defined as titers at the level of ≥ 10 mIU/mL for Hepatitis B.
    End point type
    Secondary
    End point timeframe
    1 month post-vaccination
    End point values
    		 PEDIACEL Infanrix hexa
    Number of subjects analysed
    76
    80
    Units: Percentage of subjects
    number (not applicable)
        Pre-Booster
    0
    93.7
        Post-Booster and Pre-ENGERIX-B Kinder
    93.2
    98.7
        Post-ENGERIX-B Kinder
    100
    0
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies to Hepatitis B Antigens Before and Following Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies to Hepatitis B Antigens Before and Following Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine
    End point description
    Anti-Hepatitis B antibodies were measured using enhanced chemiluminescence [ECi]).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) to 1 month post-vaccination
    End point values
    		 PEDIACEL Infanrix hexa
    Number of subjects analysed
    76
    80
    Units: Titers
    geometric mean (confidence interval 95%)
        Pre-Booster
    0 (0 to 0)
    196 (131.91 to 291.25)
        Post-Booster and Pre-ENGERIX-B Kinder
    194.48 (132.62 to 285.21)
    2866.13 (1872.12 to 4387.91)
        Post-ENGERIX-B Kinder
    9066.36 (6029.63 to 13632.49)
    0 (0 to 0)
    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 Hexa 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 Hexa Vaccine
    End point description
    Solicited injection site: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, and Irritability.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-each vaccination
    End point values
    		 PEDIACEL Infanrix hexa
    Number of subjects analysed
    422
    421
    Units: Percentage of subjects
    number (not applicable)
        Tenderness
    69
    63.7
        Erythema
    68
    68.4
        Swelling
    38.4
    35.9
        Fever
    71.8
    70.5
        Vomiting
    15.6
    14.8
        Crying abnormal
    45.5
    44.5
        Drowsiness
    50.5
    44
        Appetite loss
    49.5
    51
        Irritability
    57.3
    58.3
    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 Hexa 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 Hexa Vaccine
    End point description
    Solicited injection site: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, and 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 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 difficulty to wake up; Appetite loss – refuses ≥ 3 feeds or refuses most feeds; and Irritability– Inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-each vaccination
    End point values
    		 PEDIACEL Infanrix hexa
    Number of subjects analysed
    422
    421
    Units: Percentage of subjects
    number (not applicable)
        Tenderness (Visit 1)
    63
    63.7
        Grade 3 Tenderness (Visit 1)
    3.3
    3.3
        Tenderness (Visit 2)
    33.7
    0
        Grade 3 Tenderness (Visit 2)
    0
    0
        Erythema (Visit 1)
    62.8
    68.4
        Grade 3 Erythema (Visit 1)
    13.7
    13.3
        Erythema (Visit 2)
    24.4
    0
        Grade 3 Erythema (Visit 2)
    0
    0
        Swelling (Visit 1)
    35
    35.9
        Grade 3 Swelling (Visit 1)
    8.8
    7.4
        Swelling (Visit 2)
    9.8
    0
        Grade 3 Swelling (Visit 2)
    0.2
    0
        Fever (Visit 1)
    63.7
    65
        Grade 3 Fever (Visit 1)
    7.8
    6
        Fever (Visit 2)
    28.9
    19.4
        Grade 3 Fever (Visit 2)
    5
    3.7
        Vomiting (Visit 1)
    9.2
    11.2
        Grade 3 Vomiting (Visit 1)
    0.2
    0.7
        Vomiting (Visit 2)
    7.9
    4.3
        Grade 3 Vomiting (Visit 2)
    1
    0
        Crying abnormal (Visit 1)
    39.1
    41.2
        Grade 3 Crying abnormal (Visit 1)
    1.9
    3.3
        Crying abnormal (Visit 2)
    19.6
    13.7
        Grade 3 Crying abnormal (Visit 2)
    1.4
    1.2
        Drowsiness (Visit 1)
    39.8
    40
        Grade 3 Drowsiness (Visit 1)
    1.2
    2.1
        Drowsiness (Visit 2)
    25.1
    10.6
        Grade 3 Drowsiness (Visit 2)
    0.5
    0.7
        Appetite loss (Visit 1)
    41.5
    45.5
        Grade 3 Appetite loss (Visit 1)
    3.3
    3.8
        Appetite loss (Visit 2)
    24.2
    18.3
        Grade 3 Appetite loss (Visit 2)
    2.6
    2.4
        Irritability (Visit 1)
    51.4
    55.2
        Grade 3 Irritability (Visit 1)
    3.8
    1.7
        Irritability (Visit 2)
    29.7
    18.8
        Grade 3 Irritability (Visit 2)
    1.2
    1.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Extensive Limb Swelling Following Booster Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine

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    End point title
    		 Percentage of Subjects Reporting Extensive Limb Swelling Following Booster Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine
    End point description
    Extensive limb swelling is defined as swelling extending from the injection site beyond 1 or both adjacent joints (i.e., elbow and/or shoulder).
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-each vaccination
    End point values
    		 PEDIACEL Infanrix hexa
    Number of subjects analysed
    422
    421
    Units: Percentage of subjects
    number (not applicable)
        Extensive limb swelling
    0.5
    1.2
    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 1 month post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    PEDIACEL
    Reporting group description
    		 Subjects who received PEDIACEL (0.5 mL) as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months followed by ENGERIX-B Kinder (0.5 mL) 1 month later, at 12 to 19 months.

    Reporting group title
    Infanrix hexa
    Reporting group description
    		 Subjects who received Infanrix hexa as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months.

    Serious adverse events
    		 PEDIACEL Infanrix hexa
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 422 (2.84%)
    14 / 421 (3.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Accidental exposure
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    2 / 422 (0.47%)
    2 / 421 (0.48%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electric shock
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 422 (0.24%)
    2 / 421 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 421 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    2 / 422 (0.47%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 422 (0.24%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 421 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    3 / 422 (0.71%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 422 (0.24%)
    3 / 421 (0.71%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 421 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 421 (0.24%)
         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 hexa
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    303 / 422 (71.80%)
    296 / 421 (70.31%)
    Nervous system disorders
    Solicited injection site Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    213 / 422 (50.47%)
    185 / 420 (44.05%)
         occurrences all number
    213
    185
    General disorders and administration site conditions
    Solicited injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    291 / 422 (68.96%)
    268 / 421 (63.66%)
         occurrences all number
    291
    268
    Solicited injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    287 / 422 (68.01%)
    288 / 421 (68.41%)
         occurrences all number
    287
    288
    Solicited injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    162 / 422 (38.39%)
    151 / 421 (35.87%)
         occurrences all number
    162
    151
    Solicited injection site Fever
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    303 / 422 (71.80%)
    296 / 420 (70.48%)
         occurrences all number
    303
    296
    Gastrointestinal disorders
    Solicited injection site Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    66 / 422 (15.64%)
    62 / 420 (14.76%)
         occurrences all number
    66
    62
    Psychiatric disorders
    Solicited injection site Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    192 / 422 (45.50%)
    187 / 420 (44.52%)
         occurrences all number
    192
    187
    Solicited injection site Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    242 / 422 (57.35%)
    245 / 420 (58.33%)
         occurrences all number
    242
    245
    Metabolism and nutrition disorders
    Solicited injection site Appetite loss
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    209 / 422 (49.53%)
    214 / 420 (50.95%)
         occurrences all number
    209
    214
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jun 2006
    Infant inclusion criteria were revised to meet the current practices of infant immunizations in Germany, visit procedures were revised to standardize a definition of "whole limb swelling", List of Investigators were updated, and the consent form was further revised to clarify compliance with immunization requirements and possible benefits.
    15 Sep 2006
    Batch numbers of the vaccines were added, List of Investigators were updated, and the consent form was further revised to clarify compliance with immunization requirements.
    21 Mar 2007
    Retrospective power calculations were added, assay methodology was updated, and List of Investigators were updated.
    12 Sep 2007
    PRP testing and the List of Investigators were updated.
    14 Sep 2007
    Polio testing and the definition of fever were updated, two per protocol analysis sets were defined to reflect different testing schedules, the temperature condition for the sera storage was removed, and the CTL was updated in the List of Participants.

    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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