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    Clinical Trial Results:
    Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) as a Booster in Japanese Adolescents

    Summary
    EudraCT number
    		 2015-005628-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    11 Nov 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
    Td540
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01689324
    WHO universal trial number (UTN)
    		 U1111-1124-7671
    Sponsors
    Sponsor organisation name
    Sanofi K.K.
    Sponsor organisation address
    3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan, 163-1488
    Public contact
    Medical Director, Sanofi K.K, +81 3 6301 3603, Toshihiro.emori@sanofi.com
    Scientific contact
    Medical Director, Sanofi K.K, +81 3 6301 3603, Toshihiro.emori@sanofi.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
    04 Feb 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunogenicity of Adacel (SP306) when administered as a single dose in Japanese adolescents.
    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
    		 Subjects who were enrolled in the study were previously vaccinated with 4 doses of pediatric diphtheria, pertussis and tetanus (DTaP) vaccine.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    12 Sep 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
    Japan: 43
    Worldwide total number of subjects
    43
    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)
    25
    Adolescents (12-17 years)
    18
    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 12 September 2012 through 14 October 2012 in 3 clinic centers in Japan.

    Pre-assignment
    Screening details
    		 A total of 43 subjects that met all the inclusion criteria but none of the exclusion criteria were enrolled and vaccinated in the study.

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

    Arms
    Arm title
    		 Study Group
    Arm description
    		 Subjects received a single booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (TDaP; Adacel®) intramuscularly.
    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 in the deltoid, 1 injection on Day 0.

    Number of subjects in period 1
    		Study Group
    Started
    43
    Completed
    43

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study Group
    Reporting group description
    		 Subjects received a single booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (TDaP; Adacel®) intramuscularly.

    Reporting group values
    		 Study Group Total
    Number of subjects
    		 43 43
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 43 43
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.4 ± 0.5 -
    Gender categorical
    Units: Subjects
        Female
    		 23 23
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    Study Group
    Reporting group description
    		 Subjects received a single booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (TDaP; Adacel®) intramuscularly.

    Primary: Percentage of Subjects With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®

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    End point title
    		 Percentage of Subjects With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® [1]
    End point description
    Seroprotection was defined as the percentage of subjects with antibody concentration levels ≥0.1 IU/mL post-vaccination.
    End point type
    Primary
    End point timeframe
    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
    		 Study Group
    Number of subjects analysed
    43
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria
    100
        Tetanus
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®

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    End point title
    		 Percentage of Subjects With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® [2]
    End point description
    Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL. Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.7 IU/mL.
    End point type
    Primary
    End point timeframe
    Day 28 post-vaccination
    Notes
    [2] - 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
    Number of subjects analysed
    43
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria
    98
        Tetanus
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Booster Response to Pertussis Antigens Following Vaccination with ADACEL®

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    End point title
    		 Percentage of Subjects With Booster Response to Pertussis Antigens Following Vaccination with ADACEL® [3]
    End point description
    Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and post-vaccination levels ≥ 4X LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4X LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4X LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2).
    End point type
    Primary
    End point timeframe
    Day 28 post-vaccination
    Notes
    [3] - 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
    Number of subjects analysed
    43
    Units: Percentage of subjects
    number (not applicable)
        Pertussis toxoid
    63
        Filamentous hemagglutinin
    88
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With Seroprotection Against Diphtheria and Tetanus Antigens Pre-Vaccination With ADACEL®

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    End point title
    		 Percentage of Subjects With Seroprotection Against Diphtheria and Tetanus Antigens Pre-Vaccination With ADACEL®
    End point description
    Seroprotection was defined as the percentage of subjects with antibody concentration of ≥ 0.1 IU/mL.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 pre-vaccination
    End point values
    		 Study Group
    Number of subjects analysed
    43
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria
    63
        Tetanus
    91
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With Seroprotection Against Diphtheria and Tetanus Antigens Pre-Vaccination and Post-Vaccination With ADACEL®

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    End point title
    		 Percentage of Subjects With Seroprotection Against Diphtheria and Tetanus Antigens Pre-Vaccination and Post-Vaccination With ADACEL®
    End point description
    Seroprotection was defined as the percentage of subjects with antibody concentration of ≥ 0.01 IU/mL.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 post-vaccination
    End point values
    		 Study Group
    Number of subjects analysed
    43
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria (pre-vaccination)
    100
        Diphtheria (post-vaccination)
    100
        Tetanus (pre-vaccination)
    100
        Tetanus (post-vaccination)
    100
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With Seroprotection Against Diphtheria and Tetanus Antigens Pre-Vaccination and Post-Vaccination With ADACEL®

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    End point title
    		 Percentage of Subjects With Seroprotection Against Diphtheria and Tetanus Antigens Pre-Vaccination and Post-Vaccination With ADACEL®
    End point description
    Seroprotection was defined as the percentage of subjects with antibody concentrations ≥ 1.0 IU/mL.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 post-vaccination
    End point values
    		 Study Group
    Number of subjects analysed
    43
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria (pre-vaccination)
    12
        Diphtheria (post-vaccination)
    100
        Tetanus (pre-vaccination)
    30
        Tetanus (post-vaccination)
    100
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-Vaccination with ADACEL®

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    End point title
    		 Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-Vaccination with ADACEL®
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 post-vaccination
    End point values
    		 Study Group
    Number of subjects analysed
    43
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Diphtheria (pre-vaccination)
    0.22 (0.14 to 0.35)
        Diphtheria (post-vaccination)
    8.58 (6.76 to 10.88)
        Tetanus (pre-vaccination)
    0.46 (0.33 to 0.64)
        Tetanus (post-vaccination)
    37.8 (30.16 to 47.38)
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-Vaccination with ADACEL®

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    End point title
    		 Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-Vaccination with ADACEL®
    End point description
    Pertussis immune response was measured using Japanese standard enzyme-linked immunosorbent assay.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 post-vaccination
    End point values
    		 Study Group
    Number of subjects analysed
    43
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Pertussis toxoid (pre-vaccination)
    12.21 (7.82 to 19.05)
        Pertussis toxoid (post-vaccination)
    46.92 (33.65 to 65.42)
        Filamentous hemagglutinin (pre-vaccination)
    34.79 (23.47 to 51.57)
        Filamentous hemagglutinin (post-vaccination)
    204 (164.26 to 253.36)
        Pertactin (pre-vaccination)
    10.64 (6.28 to 18.03)
        Pertactin (post-vaccination)
    272.82 (197.63 to 376.62)
        Fimbriae types 2 and 3 (pre-vaccination)
    7.78 (5.42 to 11.17)
        Fimbriae types 2 and 3 (post-vaccination)
    748.28 (443.23 to 1263.27)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With Booster Response to Pertussis Antigens Following Vaccination with ADACEL®

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    End point title
    		 Percentage of Subjects With Booster Response to Pertussis Antigens Following Vaccination with ADACEL®
    End point description
    Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination level ≥ 4X LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4X LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4X LLOQ and a 2-fold rise (i.e., post-/pre-vaccination) ≥ 2).
    End point type
    Other pre-specified
    End point timeframe
    Day 28 post-vaccination
    End point values
    		 Study Group
    Number of subjects analysed
    43
    Units: Percentage of subjects
    number (not applicable)
        Pertactin
    93
        Fimbriae Types 2 and 3
    98
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With ADACEL®

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    End point title
    		 Number of Subjects Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With ADACEL®
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Erythema and Swelling, > 100 mm. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    		 Study Group
    Number of subjects analysed
    43
    Units: Number of subjects
    number (not applicable)
        Solicited Injection site Pain
    37
        Grade 3 Solicited Injection site Pain
    0
        Solicited Injection site Erythema
    9
        Grade 3 Solicited Injection site Erythema
    0
        Solicited Injection site Swelling
    12
        Grade 3 Solicited Injection site Swelling
    1
        Fever
    9
        Grade 3 Fever
    1
        Headache
    8
        Grade 3 Headache
    0
        Malaise
    11
        Grade 3 Malaise
    0
        Myalgia
    17
        Grade 3 Myalgia
    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 (post-vaccination) up to 1 month post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Study Group
    Reporting group description
    		 Subjects received a single booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (TDaP; Adacel®) intramuscularly.

    Serious adverse events
    		 Study Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 43 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Study Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 43 (90.70%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 43 (18.60%)
         occurrences all number
    8
    General disorders and administration site conditions
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    37 / 43 (86.05%)
         occurrences all number
    37
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 43 (20.93%)
         occurrences all number
    9
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 43 (27.91%)
         occurrences all number
    12
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 43 (20.93%)
         occurrences all number
    9
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 43 (25.58%)
         occurrences all number
    11
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 43 (39.53%)
         occurrences all number
    17
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 43 (16.28%)
         occurrences all number
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Nov 2012
    Revised observational endpoints and immunogenicity assessment methods to note that the pertussis immune response would be characterized by a Japanese laboratory using a enzyme-linked immunosorbent assay kit, and updated the storage and shipment procedures.

    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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