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    Clinical Trial Results:
    Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents

    Summary
    EudraCT number
    		 2015-005629-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 Sep 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2016
    First version publication date
    19 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Td551
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01629589
    WHO universal trial number (UTN)
    		 U1111-1127-6774
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    1 Discovery Drive, Swiftwater, United States, 18370
    Public contact
    Medical Team Leader, Scientific and Medical Affairs Department, Sanofi Pasteur Inc., 1 570-957-5433, vitali.pool@sanofipasteur.com
    Scientific contact
    Medical Team Leader, Scientific and Medical Affairs Department, Sanofi Pasteur Inc., 1 570-957-5433, vitali.pool@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
    08 May 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity • To describe seroprotection rates against tetanus and diphtheria in subjects randomized to receive either Adacel or Boostrix vaccine. • To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean antibody concentrations (GMCs) in subjects randomized to receive either Adacel or Boostrix vaccine. • To describe booster response rates against tetanus, diphtheria, and pertussis in subjects randomized to receive either Adacel or Boostrix vaccine.
    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
    20 Jun 2012
    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
    United States: 423
    Worldwide total number of subjects
    423
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    423
    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
    		 The study subjects were enrolled from 20 June 2012 to 10 September 2012 at 8 centers in the United States.

    Pre-assignment
    Screening details
    		 A total of 423 subjects that met all of the inclusion and none of the exclusion criteria were randomized, 422 were vaccinated in this study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adacel® Vaccine Group
    Arm description
    		 Subjects received a single dose of Adacel® vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection on Day 0.

    Arm title
    		 BOOSTRIX® Vaccine Group
    Arm description
    		 Subjects received a single dose of BOOSTRIX® vaccine.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tetanus toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (BOOSTRIX®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection on Day 0.

    Number of subjects in period 1
    		Adacel® Vaccine Group BOOSTRIX® Vaccine Group
    Started
    212
    211
    Completed
    204
    204
    Not completed
    8
    7
         Consent withdrawn by subject
    2
    3
         Did not receive study vaccine
    -
    1
         Lost to follow-up
    2
    1
         Protocol deviation
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adacel® Vaccine Group
    Reporting group description
    		 Subjects received a single dose of Adacel® vaccine.

    Reporting group title
    BOOSTRIX® Vaccine Group
    Reporting group description
    		 Subjects received a single dose of BOOSTRIX® vaccine.

    Reporting group values
    		 Adacel® Vaccine Group BOOSTRIX® Vaccine Group Total
    Number of subjects
    		 212 211 423
    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)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 212 211 423
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.6 ± 0.5 11.6 ± 0.5 -
    Gender categorical
    Units: Subjects
        Female
    		 105 106 211
        Male
    		 107 105 212

    End points

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    End points reporting groups
    Reporting group title
    Adacel® Vaccine Group
    Reporting group description
    		 Subjects received a single dose of Adacel® vaccine.

    Reporting group title
    BOOSTRIX® Vaccine Group
    Reporting group description
    		 Subjects received a single dose of BOOSTRIX® vaccine.

    Primary: Number of Subjects With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX®

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    End point title
    		 Number of Subjects With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® [1]
    End point description
    Tetanus antibody was assayed by enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥ 0.1 IU/mL and ≥ 1.0 IU/mL.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 (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
    		 Adacel® Vaccine Group BOOSTRIX® Vaccine Group
    Number of subjects analysed
    196
    194
    Units: Number of subjects
    number (not applicable)
        Tetanus (pre-vaccination); ≥ 0.1 IU/mL
    172
    177
        Tetanus (post-vaccination); ≥ 0.1 IU/mL
    196
    194
        Diphtheria (pre-vaccination); ≥ 0.1 IU/mL
    135
    139
        Diphtheria (post-vaccination); ≥ 0.1 IU/mL
    196
    194
        Tetanus (pre-vaccination); ≥ 1.0 IU/mL
    33
    48
        Tetanus (post-vaccination); ≥ 1.0 IU/mL
    195
    194
        Diphtheria (pre-vaccination); ≥ 1.0 IU/mL
    28
    26
        Diphtheria (post-vaccination); ≥ 1.0 IU/mL
    183
    186
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine

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    End point title
    		 Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
    End point description
    Tetanus antibody was assayed by enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) to Day 28 post-vaccination
    End point values
    		 Adacel® Vaccine Group BOOSTRIX® Vaccine Group
    Number of subjects analysed
    196
    194
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Tetanus (pre-vaccination)
    0.422 (0.363 to 0.492)
    0.456 (0.393 to 0.528)
        Tetanus (post-vaccination)
    18.9 (16.4 to 21.8)
    9.18 (8.1 to 10.4)
        Diphtheria (pre-vaccination)
    0.211 (0.171 to 0.26)
    0.221 (0.181 to 0.269)
        Diphtheria (post-vaccination)
    8.17 (6.83 to 9.77)
    5.62 (4.85 to 6.51)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine

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    End point title
    		 Number of Subjects With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
    End point description
    Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤ 2.56 IU/mL for diphtheria and ≤ 2.7 IU/mL for tetanus, and defined as a 2-fold increase for subjects with a pre-vaccination concentration > 2.56 IU/mL for diphtheria and > 2.7 IU/mL for tetanus. Boostrix booster response defined as: a post-vaccination titer ≥ 4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer < LLOQ, a post-vaccination titer ≥ 4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4X LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥ 4X LLOQ.
    End point type
    Secondary
    End point timeframe
    Day 28 post-vaccination
    End point values
    		 Adacel® Vaccine Group BOOSTRIX® Vaccine Group
    Number of subjects analysed
    196
    194
    Units: Number of subjects
    number (not applicable)
        Tetanus
    194
    191
        Diphtheria
    189
    188
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations of Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine

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    End point title
    		 Geometric Mean Concentrations of Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
    End point description
    Pertussis antibodies Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM 2&3) were assayed by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) to Day 28 post-vaccination
    End point values
    		 Adacel® Vaccine Group BOOSTRIX® Vaccine Group
    Number of subjects analysed
    196
    194
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Pertussis toxoid (pre-vaccination)
    5.59 (4.67 to 6.68)
    5.69 (4.71 to 6.88)
        Pertussis toxoid (post-vaccination)
    31 (27 to 35.7)
    44.1 (39 to 49.9)
        Filamentous hemagglutinin (pre-vaccination)
    22.7 (19 to 27.2)
    22.7 (19.4 to 26.6)
        Filamentous hemagglutinin (post-vaccination)
    255 (228 to 286)
    318 (292 to 347)
        Pertactin (pre-vaccination)
    12.3 (10.5 to 14.4)
    10.3 (8.99 to 11.9)
        Pertactin (post-vaccination)
    263 (223 to 310)
    252 (214 to 295)
        Fimbriae types 2 and 3 (pre-vaccination)
    5.95 (4.88 to 7.24)
    6.55 (5.33 to 8.04)
        Fimbriae types 2 and 3 (post-vaccination)
    346 (269 to 446)
    11.1 (8.79 to 14)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Booster Responses Against Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine

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    End point title
    		 Number of Subjects With Booster Responses Against Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
    End point description
    Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤ 93 ELISA Unit (EU)/mL for Pertussis toxoid (PT), ≤ 170 EU/mL for Filamentous hemagglutinin (FHA), ≤ 115 EU/mL for pertactin (PRN), or ≤ 285 EU/mL for Fimbriae types 2 and 3 (FIM), and defined as a 2-fold increase for subjects with a pre-vaccination concentration > 93 EU/mL for PT, > 170 EU/mL for FHA, > 115 EU/mL for PRN, or > 285 EU/mL for FIM. Boostrix booster response defined as: a post-vaccination titer ≥ 4 times the LLOQ for subjects with a pre-vaccination titer < LLOQ, a post-vaccination titer ≥ 4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4X LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥ 4X LLOQ.
    End point type
    Secondary
    End point timeframe
    Day 28 post-vaccination
    End point values
    		 Adacel® Vaccine Group BOOSTRIX® Vaccine Group
    Number of subjects analysed
    196
    194
    Units: Number of subjects
    number (not applicable)
        Pertussis toxoid
    97
    142
        Filamentous hemagglutinin
    167
    189
        Pertactin
    186
    189
        Fimbriae types 2 and 3
    181
    31
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine

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    End point title
    		 Number of Subjects Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
    End point description
    The occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination and systemic AEs.
    End point type
    Secondary
    End point timeframe
    Up to 15 minutes post-vaccination
    End point values
    		 Adacel® Vaccine Group BOOSTRIX® Vaccine Group
    Number of subjects analysed
    211
    211
    Units: Number of subjects
    number (not applicable)
        Headache
    1
    0
        Nausea
    1
    0
    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 28 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Adacel® Vaccine Group
    Reporting group description
    		 Subjects received a single dose of Adacel® vaccine.

    Reporting group title
    BOOSTRIX® Vaccine Group
    Reporting group description
    		 Subjects received a single dose of BOOSTRIX® vaccine.

    Serious adverse events
    		 Adacel® Vaccine Group BOOSTRIX® Vaccine Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 211 (0.00%)
    0 / 211 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adacel® Vaccine Group BOOSTRIX® Vaccine Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 211 (27.49%)
    70 / 211 (33.18%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 211 (9.95%)
    31 / 211 (14.69%)
         occurrences all number
    26
    39
    General disorders and administration site conditions
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    34 / 211 (16.11%)
    43 / 211 (20.38%)
         occurrences all number
    36
    46
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 211 (5.21%)
    4 / 211 (1.90%)
         occurrences all number
    11
    5

    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.
    None reported
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