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    Clinical Trial Results:
    Comparison of Pertussis Specific Cellular and Humoral Immunity Before and After a Acellular Pertussis Booster-Vaccination in Combination With a Diphtheria-Tetanus-Polio-Vaccine Between Three Groups of Adolescents 10-14 Years of Age That Have Previously Either Received 4 or 5 Doses of Acellular Pertussis Vaccine or 4 Doses of Whole-Cell Pertussis Vaccine

    Summary
    EudraCT number
    		 2005-005532-27
    Trial protocol
    		 DE  
    Global end of trial date
    31 Oct 2006

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

    Trial information

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    Trial identification
    Sponsor protocol code
    PERTIMMUN06
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur
    Sponsor organisation address
    1 Discovery Drive, Swiftwater, United States, 18370
    Public contact
    Vice President and Global Medical Expert, Sanofi Pasteur, +1 5709571506, Dr.Johnson@sanofipasteur.com
    Scientific contact
    Vice President and Global Medical Expert, Sanofi Pasteur, +1 5709571506, Dr.Johnson@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Sep 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the pertussis-specific humoral and cellular immunity after vaccination with REPEVAX® or COVAXiS® + IPV Merieux® among 3 groups: Group A: Adolescents 10-14 years of age who had received five doses of acellular pertussis vaccine and who simultaneously participated in the TRI05 study in which they received either REPEVAX® or COVAXiS® + IPV Merieux® based on on their randomization group. Group B: Adolescents 10-14 years of age who previously received four doses of acellular pertussis vaccine. Subjects of group B could not participate in the TRI05 study, and in this study received either REPEVAX® or COVAXiS® + IPV Merieux® as recommended by their physician. Group C: Adolescents 10-14 years of age who previously received four doses of whole-cell pertussis vaccine and had not yet received acellular pertussis vaccine and who simultaneously participated in the TRI05 study in which they had received either REPEVAX® or COVAXiS® + IPV Merieux® based on their randomization group.
    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
    		 Subjects may have received a 5th consecutive aP immunization at 4 - 6 years of age (which became part of the official German recommendations in March 2006) or have received only 4 consecutive aP or wP immunizations (last dose at 18-24 months).
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    01 Feb 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 78
    Worldwide total number of subjects
    78
    EEA total number of subjects
    78
    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)
    0
    Children (2-11 years)
    22
    Adolescents (12-17 years)
    56
    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 01 February 2006 to 16 August 2006 at 17 clinical centers in Germany.

    Pre-assignment
    Screening details
    		 A total of 78 subjects who met 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
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Study Group A
    Arm description
    		 Adolescents 10 - 14 years of age, who had already been given 5 doses of an acellular pertussis vaccine combined with diphtheria and tetanus toxoids (at that time Biken DTaP, last at the age of 4 to 6 years).
    Arm type
    		 Experimental

    Investigational medicinal product name
    REPEVAX
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single 0.5 ml dose

    Investigational medicinal product name
    COVAXiS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single 0.5 mL dose

    Arm title
    		 Study Group B
    Arm description
    		 Adolescents 10-14 years of age, who had previously received 4 doses of acellular pertussis vaccine combined with diphtheria and tetanus toxoids (at that time Biken DTaP, last at the age of 18 to 24 months).
    Arm type
    		 Experimental

    Investigational medicinal product name
    REPEVAX
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single 0.5 ml dose

    Investigational medicinal product name
    COVAXiS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single 0.5 mL dose

    Arm title
    		 Study Group C
    Arm description
    		 Adolescents 10 - 14 years of age, who had already received 4 doses of whole-cell pertussis vaccine combined with diphtheria and tetanus toxoids (last at the age of 18 to 24 months) and who had so far not received an acellular pertussis vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    REPEVAX
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single 0.5 ml dose

    Investigational medicinal product name
    COVAXiS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single 0.5 mL dose

    Number of subjects in period 1
    		Study Group A Study Group B Study Group C
    Started
    37
    23
    18
    Completed
    37
    23
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study Group A
    Reporting group description
    		 Adolescents 10 - 14 years of age, who had already been given 5 doses of an acellular pertussis vaccine combined with diphtheria and tetanus toxoids (at that time Biken DTaP, last at the age of 4 to 6 years).

    Reporting group title
    Study Group B
    Reporting group description
    		 Adolescents 10-14 years of age, who had previously received 4 doses of acellular pertussis vaccine combined with diphtheria and tetanus toxoids (at that time Biken DTaP, last at the age of 18 to 24 months).

    Reporting group title
    Study Group C
    Reporting group description
    		 Adolescents 10 - 14 years of age, who had already received 4 doses of whole-cell pertussis vaccine combined with diphtheria and tetanus toxoids (last at the age of 18 to 24 months) and who had so far not received an acellular pertussis vaccine.

    Reporting group values
    		 Study Group A Study Group B Study Group C Total
    Number of subjects
    		 37 23 18 78
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 17 5 0 22
        Adolescents (12-17 years)
    		 20 18 18 56
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.2 ( 0.2 ) 12 ( 0.5 ) 13.3 ( 0.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 12 6 33
        Male
    		 22 11 12 45

    End points

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    End points reporting groups
    Reporting group title
    Study Group A
    Reporting group description
    		 Adolescents 10 - 14 years of age, who had already been given 5 doses of an acellular pertussis vaccine combined with diphtheria and tetanus toxoids (at that time Biken DTaP, last at the age of 4 to 6 years).

    Reporting group title
    Study Group B
    Reporting group description
    		 Adolescents 10-14 years of age, who had previously received 4 doses of acellular pertussis vaccine combined with diphtheria and tetanus toxoids (at that time Biken DTaP, last at the age of 18 to 24 months).

    Reporting group title
    Study Group C
    Reporting group description
    		 Adolescents 10 - 14 years of age, who had already received 4 doses of whole-cell pertussis vaccine combined with diphtheria and tetanus toxoids (last at the age of 18 to 24 months) and who had so far not received an acellular pertussis vaccine.

    Primary: Summary of Geometric Mean Titers (GMTs) of Pertussis Antibodies Before and After a Acellular Pertussis Booster Vaccination

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    End point title
    		 Summary of Geometric Mean Titers (GMTs) of Pertussis Antibodies Before and After a Acellular Pertussis Booster Vaccination [1]
    End point description
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and 1 month post-vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Study Group A Study Group B Study Group C
    Number of subjects analysed
    37
    23
    18
    Units: EU/mL
    geometric mean (confidence interval 95%)
        IgG-Pertussis toxoid (pre-vaccination)
    4.22 (3.24 to 5.48)
    3.85 (2.83 to 5.25)
    9.7 (4.18 to 22.47)
        IgG-Pertussis toxoid (post-vaccination)
    16.35 (11.35 to 23.55)
    17.06 (9.66 to 30.14)
    50.33 (26.13 to 96.96)
        IgG-Filamentous hemagglutinin (pre-vaccination)
    25.19 (16.78 to 37.82)
    14.98 (9.39 to 23.9)
    10.67 (5.21 to 21.89)
        igG-Filamentous hemagglutinin (post-vaccination)
    160.97 (122.34 to 211.81)
    127.04 (89.09 to 181.15)
    135.57 (98.94 to 191.28)
        igG-Pertactin (pre-vaccination)
    18.78 (12.5 to 28.21)
    13.33 (6.34 to 28.02)
    13.95 (6.3 to 30.87)
        igG-Pertactin (post-vaccination)
    600.72 (449.61 to 802.63)
    407.34 (260.6 to 636.7)
    638.95 (370.02 to 1103.33)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with positive cell mediated immunity-response against Pertussis Toxoid (PT) Before and After Acellular Pertussis Booster Vaccination.

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    End point title
    		 Percentage of Subjects with positive cell mediated immunity-response against Pertussis Toxoid (PT) Before and After Acellular Pertussis Booster Vaccination.
    End point description
    A positive cell mediated immunity-response against PT is defined as a simulation index of ≥ 4.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (Day 0) and Day 28 to 36 post-vaccination
    End point values
    		 Study Group A Study Group B Study Group C
    Number of subjects analysed
    37
    21
    17
    Units: Percentage
    number (not applicable)
        Pre-vaccination
    38
    43
    53
        Post-vaccination
    62
    81
    77
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with positive Cell mediated immunity-response against Filamentous Hemagglutinin Before and After Acellular Pertussis Booster Vaccination.

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    End point title
    		 Percentage of Subjects with positive Cell mediated immunity-response against Filamentous Hemagglutinin Before and After Acellular Pertussis Booster Vaccination.
    End point description
    A positive cell mediated immunity-response against Filamentous Hemagglutinin was defined as a stimulation index (SI) of ≥4.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (Day 0) and Day 28-36 Post-vaccination
    End point values
    		 Study Group A Study Group B Study Group C
    Number of subjects analysed
    37
    21
    17
    Units: Percentage
    number (not applicable)
        Pre-vaccination
    78
    62
    65
        Post-vaccination
    87
    95
    94
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with positive Cell mediated immunity-response against Pertactin Before and After Acellular Pertussis Booster Vaccination.

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    End point title
    		 Percentage of Subjects with positive Cell mediated immunity-response against Pertactin Before and After Acellular Pertussis Booster Vaccination.
    End point description
    A positive cell mediated immunity-response against Pertactin was defined as a stimulation index (SI) of ≥4.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (Day 0) and Day 28-36 Post-vaccination
    End point values
    		 Study Group A Study Group B Study Group C
    Number of subjects analysed
    37
    21
    17
    Units: Percentage
    number (not applicable)
        Pre-vaccination
    35
    62
    53
        Post-vaccination
    68
    71
    82
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with positive Cell mediated immunity-response against Fimbriae type 2/3 Before and After Acellular Pertussis Booster Vaccination.

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    End point title
    		 Percentage of Subjects with positive Cell mediated immunity-response against Fimbriae type 2/3 Before and After Acellular Pertussis Booster Vaccination.
    End point description
    A positive cell mediated immunity-response against Fimbriae type 2/3 (FIM) was defined as a stimulation index (SI) of ≥4.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (Day 0) and Day 28 to 36 Post-vaccination
    End point values
    		 Study Group A Study Group B Study Group C
    Number of subjects analysed
    37
    21
    17
    Units: Percentage
    number (not applicable)
        Pre-vaccination
    60
    52
    53
        Post-vaccination
    73
    76
    82
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Safety outcomes including adverse events information were not part of this protocol and were not solicited during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    6.0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Safety outcomes including adverse events information were not part of this protocol and were not solicited during the study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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    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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