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    Clinical Trial Results:
    Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to Infanrix Hexa™, Both Concomitantly Administered With Prevnar™ at 2, 4, and 6 Months of Age in Thai Infants.

    Summary
    EudraCT number
    		 2011-004457-87
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Nov 2007

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

    Trial information

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    Trial identification
    Sponsor protocol code
    A3L12
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00401531
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur, SA
    Sponsor organisation address
    1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 58 43 , emmanuel.feroldi@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 58 43 , emmanuel.feroldi@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001201-PIP01-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Aug 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP~T combined vaccine induces an immune response that is at least as good as the response following Infanrix hexa™ in terms of seroprotection rates to Hep B and PRP, 1 month after a three-dose primary series (at 2, 4, and 6 months), when co-administered with Prevnar™.
    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. They were also followed up for a total of 300 days (including a 6 month safety follow up for SAEs) after the last vacine dose.
    Background therapy
    		 All subjects in the study must have received Hep B vaccination at birth in order to comply with the Thai Standard Vaccination Schedule.
    Evidence for comparator
    		 Infanrix hexa™ is a licensed DTap/Hib/IPV/Hep B vaccine given in a three doses primary series vaccination.
    Actual start date of recruitment
    22 Oct 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Thailand: 412
    Worldwide total number of subjects
    412
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    412
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study participants were enrolled from 22 October 2006 to 19 November 2007 in 4 clinical centers in Thailand

    Pre-assignment
    Screening details
    		 Only participants who met all the inclusion, but none of the exclusion criteria were enrolled and vaccinated

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DTaP-IPV-Hep B-PRP-T + Prevnar™
    Arm description
    		 Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hexaxim
    Investigational medicinal product code
    DTaP-IPV-HepB-PRP-T vaccine
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, at 2, 4, and 6 months of age.

    Arm title
    		 Infanrix Hexa™ + Prevnar™
    Arm description
    		 Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Infanrix hexa™
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL at 2, 4, and 6 months of age.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The study was designed to have the investigator (blind observer or assessor) and subject’s parents or guardians masked for the study vaccine administered to the participants.
    Number of subjects in period 1
    		DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
    Started
    206
    206
    Completed
    197
    196
    Not completed
    9
    10
         Consent withdrawn by subject
    3
    2
         Adverse event, non-fatal
    2
    -
         Lost to follow-up
    1
    1
         Protocol deviation
    3
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP-T + Prevnar™
    Reporting group description
    		 Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.

    Reporting group title
    Infanrix Hexa™ + Prevnar™
    Reporting group description
    		 Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.

    Reporting group values
    		 DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™ Total
    Number of subjects
    		 206 206 412
    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)
    		 206 206 412
        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)
    		 1.88 ( 0.17 ) 1.9 ( 0.187 ) -
    Gender categorical
    Units: Subjects
        Female
    		 94 111 205
        Male
    		 112 95 207

    End points

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    End points reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP-T + Prevnar™
    Reporting group description
    		 Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.

    Reporting group title
    Infanrix Hexa™ + Prevnar™
    Reporting group description
    		 Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.

    Primary: Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™

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    End point title
    		 Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
    End point description
    Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.
    End point type
    Primary
    End point timeframe
    Day 150 post-dose 1
    End point values
    		 DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
    Number of subjects analysed
    189
    190
    Units: Participants
        Anti-Hepatitis B
    187
    189
        Anti-PRP
    183
    183
    Statistical analysis title
    		 Non inferiority of Hep B Seroprotection
    Statistical analysis description
    The differences in seroprotection rates for the Hep B and PRP antigens between the two groups (Test – Control) were calculated. The non inferiority margin for Hep B and PRP antigens was set to be –10%. The statistical method was based on the lower bound of the two sided 95% confidence interval (CI) of the difference of the seroprotection rates.
    Comparison groups
    Infanrix Hexa™ + Prevnar™ v DTaP-IPV-Hep B-PRP-T + Prevnar™
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 > 10 [2]
    Method
    		 Wilson score
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.46
         upper limit
    		 2.43
    Notes
    [1] - The 95% CI was calculated based on the Wilson score method without continuity correction as described by Newcombe. For each antigen, non inferiority for valence i was to be demonstrated if the lower limit of the two sided 95% CI was greater than -10. The primary objective (non inferiority of the investigational DTaP IPV Hep B PRP T vaccine) was not rejected for the Hep B and PRP since the lower bounds were > -10%.
    [2] - P-value was set at > -10%.
    Statistical analysis title
    		 Non inferiority of PRP Seroprotection
    Statistical analysis description
    The differences in seroprotection rates for the Hep B and PRP antigens between the two groups (Test – Control) were calculated. The non-inferiority margin for Hep B and PRP antigens was set to be –10%. The statistical method was based on the lower bound of the two sided 95% confidence interval (CI) of the difference of the seroprotection rates.
    Comparison groups
    Infanrix Hexa™ + Prevnar™ v DTaP-IPV-Hep B-PRP-T + Prevnar™
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 > 10 [4]
    Method
    		 Wilson score
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.15
         upper limit
    		 5.51
    Notes
    [3] - The 95% CI was calculated based on the Wilson score method without continuity correction as described by Newcombe. For each antigen, non-inferiority for valence i was to be demonstrated if the lower limit of the two sided 95% CI was greater than -10. The primary objective (non-inferiority of the investigational DTaP IPV Hep B PRP T vaccine) was not rejected for the Hep B and PRP since the lower bounds were > -10%.
    [4] - P-value was set at > -10%

    Secondary: Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™

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    End point title
    		 Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
    End point description
    Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.
    End point type
    Secondary
    End point timeframe
    Day 150 post-dose 1
    End point values
    		 DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
    Number of subjects analysed
    189
    190
    Units: Participants
        Anti-Diphtheria
    184
    190
        Anti-Tetanus
    189
    190
    No statistical analyses for this end point

    Secondary: Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™

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    End point title
    		 Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
    End point description
    Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil
    End point type
    Secondary
    End point timeframe
    Day 150 post-dose 1
    End point values
    		 DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
    Number of subjects analysed
    187
    186
    Units: Participants
        Anti-Polio Type 1
    187
    186
        Anti-Polio Type 2
    187
    186
        Anti-Polio Type 3
    187
    185
    No statistical analyses for this end point

    Secondary: Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™

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    End point title
    		 Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
    End point description
    Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.
    End point type
    Secondary
    End point timeframe
    Day 150 post-dose 1
    End point values
    		 DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
    Number of subjects analysed
    189
    190
    Units: Participants
        Anti-Pertussis toxoid
    177
    177
        Anti-Filamentous hemagglutinin
    177
    179
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™

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    End point title
    		 Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
    End point description
    Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.
    End point type
    Secondary
    End point timeframe
    Day 150 post-dose 1
    End point values
    		 DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
    Number of subjects analysed
    189
    190
    Units: titre
    geometric mean (confidence interval 95%)
        Anti-Hepatitis B
    2477 (2044 to 3002)
    2442 (2096 to 2844)
        Anti-PRP
    5.07 (4.05 to 6.33)
    2.41 (1.95 to 2.98)
        Anti-Diphtheria
    0.297 (0.241 to 0.367)
    0.209 (0.177 to 0.247)
        Anti-Tetanus
    1.38 (1.25 to 1.52)
    1.83 (1.69 to 1.97)
        Anti-Polio Type 1
    765 (649 to 902)
    1566 (1326 to 1850)
        Anti-Polio Type 2
    1489 (1259 to 1761)
    2277 (1905 to 2723)
        Anti-Polio Type 3
    837 (695 to 1007)
    2029 (1646 to 2502)
        Anti-Pertussis toxoid
    168 (154 to 183)
    200 (185 to 216)
        Anti-Filamentous hemagglutinin
    148 (136 to 162)
    123 (113 to 132)
    No statistical analyses for this end point

    Secondary: Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™

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    End point title
    		 Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
    End point description
    Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3: Pyrexia, >39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    		 DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
    Number of subjects analysed
    206
    206
    Units: Participants
        Injection site Pain post-dose 1
    161
    135
        Injection site Pain post-dose 2
    136
    118
        Injection site Pain post-dose 3
    119
    112
        Injection site Pain post-any dose
    180
    166
        Grade 3 Injection site Pain post-any dose
    20
    12
        Injection site Erythema post-dose 1
    79
    64
        Injection site Erythema post-dose 2
    93
    91
        Injection site Erythema post-dose 3
    86
    79
        Injection site Erythema post-any dose
    121
    114
        Grade 3 Injection site Erythema post-any dose
    3
    2
        Injection site Swelling post-dose 1
    59
    34
        Injection site Swelling post-dose 2
    52
    44
        Injection site Swelling post-dose 3
    34
    32
        Injection site Swelling post-any dose
    85
    65
        Grade 3 Injection site Swelling post-and dose
    1
    1
        Pyrexia post-dose 1
    109
    68
        Pyrexia post-dose 2
    84
    79
        Pyrexia post-dose 3
    81
    81
        Pyrexia post-any dose
    152
    131
        Grade 3 Pyrexia post-any dose
    6
    7
        Vomiting post-dose 1
    47
    56
        Vomiting post-dose 2
    28
    32
        Vomiting post-dose 3
    22
    28
        Vomiting post-any dose
    77
    82
        Grade 3 Vomiting post-any dose
    1
    3
        Crying post-dose 1
    128
    106
        Crying post-dose 2
    106
    104
        Crying post-dose 3
    77
    75
        Crying post-any dose
    167
    153
        Grade 3 Crying post-any dose
    7
    5
        Somnolence post-dose 1
    109
    104
        Somnolence post-dose 2
    91
    79
        Somnolence post-dose 3
    55
    59
        Somnolence post-any dose
    141
    125
        Grade 3 Somnolence post-any dose
    4
    0
        Anorexia post-dose 1
    59
    49
        Anorexia post-dose 2
    44
    40
        Anorexia post-dose 3
    36
    37
        Anorexia post-any dose
    91
    83
        Grade 3 Anorexia post-any dose
    0
    0
        Irritability post-dose 1
    134
    122
        Irritability post-dose 2
    107
    109
        Irritability post-dose 3
    90
    88
        Irritability post-any dose
    162
    159
        Grade 3 Irritability post-any dose
    4
    6
    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 following vaccination (Day 0) up to 10 months post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP-T + Prevnar™
    Reporting group description
    		 Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.

    Reporting group title
    Infanrix Hexa™ + Prevnar™
    Reporting group description
    		 Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.

    Serious adverse events
    		 DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 206 (2.91%)
    8 / 206 (3.88%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Cryptorchism
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioneurotic Oedema
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 206 (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
    1 / 206 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema Herpeticum
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 206 (0.00%)
    3 / 206 (1.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethritis
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 206 (0.49%)
         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
    1 / 206 (0.49%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
    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
    		 DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    161 / 206 (78.16%)
    135 / 206 (65.53%)
    Nervous system disorders
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed
    109 / 206 (52.91%)
    104 / 206 (50.49%)
         occurrences all number
    109
    104
    General disorders and administration site conditions
    InjectionsSite erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    93 / 206 (45.15%)
    91 / 206 (44.17%)
         occurrences all number
    93
    91
    Injection Site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    161 / 206 (78.16%)
    135 / 206 (65.53%)
         occurrences all number
    161
    135
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    59 / 206 (28.64%)
    44 / 206 (21.36%)
         occurrences all number
    59
    44
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    134 / 206 (65.05%)
    122 / 206 (59.22%)
         occurrences all number
    134
    122
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    109 / 206 (52.91%)
    68 / 206 (33.01%)
         occurrences all number
    109
    68
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 206 (3.40%)
    13 / 206 (6.31%)
         occurrences all number
    7
    13
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    47 / 206 (22.82%)
    56 / 206 (27.18%)
         occurrences all number
    47
    56
    Psychiatric disorders
    Crying
    alternative assessment type: Systematic
         subjects affected / exposed
    128 / 206 (62.14%)
    106 / 206 (51.46%)
         occurrences all number
    128
    106
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    31 / 206 (15.05%)
    35 / 206 (16.99%)
         occurrences all number
    31
    35
    Upper Respiratory Tract Infection
         subjects affected / exposed
    45 / 206 (21.84%)
    46 / 206 (22.33%)
         occurrences all number
    45
    46
    Metabolism and nutrition disorders
    Anorexia
    alternative assessment type: Systematic
         subjects affected / exposed
    59 / 206 (28.64%)
    49 / 206 (23.79%)
         occurrences all number
    59
    49

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jul 2006
    The amendment included in the version 3.0 of the protocol include changes in the logistics of the supply of the investigational and control vaccines and the handling of blood samples.

    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.
    Not applicable.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/21334243
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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