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    Clinical Trial Results:
    Immunogenicity and safety of the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (SP306) given intramuscularly compared to Diphtheria and Tetanus toxoids adsorbed (DT) given subcutaneously in Japanese adolescents 11 – 12 years of age

    Summary
    EudraCT number
    2015-003950-41
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    05 Jul 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    Td536 (EFC12579)
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02089347
    WHO universal trial number (UTN)
    U1111-1124-7550
    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, Toshiro.emori@sanofi.com
    Scientific contact
    Medical Director, Sanofi K.K, +81 3 6301 3603, Toshiro.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
    05 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of SP306 versus DT (DT Biken 0.1 mL) vaccine in terms of diphtheria and tetanus booster response rate (proportion of subjects with booster responses) and seroprotection rate (percentage of subjects with antitoxin concentrations ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age. To evaluate the immune response of SP306 against the pertussis antigens (pertussis toxoid [PT] and filamentous hemagglutinin [FHA]) in terms of booster response rate (proportion of subjects with booster responses) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years 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 was also available on site in case of any immediate allergic reactions.
    Background therapy
    Subjects were previously vaccinated with 4 doses of pediatric Diphtheria, Tetanus toxoid and acellular Pertussis vaccine adsorbed (DTaP).
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    01 Mar 2014
    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: 534
    Worldwide total number of subjects
    534
    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)
    418
    Adolescents (12-17 years)
    116
    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 01 March 2014 through 31 May 2014 at 21 clinic centers in Japan.

    Pre-assignment
    Screening details
    A total of 533 subjects who met all of the inclusion criteria - including having completed childhood vaccination against diphtheria, pertussis and tetanus (i.e., received 4 doses of Japanese-produced DTaP vaccine), and none of the exclusion criteria were randomized and 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
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    This was a modified double-blind study in which only the Investigator and limited, authorized, unblinded staff knew the group assignments since each vaccine had different dosing quantities and routes of administration. To maintain the blind, the vaccine was prepared and administered in separate rooms and the route of injection was not recorded. Subjects, parents, and safety assessors were blinded. In the event of emergencies, the code could be broken based on code-breaking procedures.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SP306 Group
    Arm description
    Subjects received 1 dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306, Tdap5) vaccine intramuscularly.
    Arm type
    Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306, Tdap5)
    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 central region of deltoid, 1 injection on Day 0.

    Arm title
    DT Biken Group
    Arm description
    Subjects received 1 dose of Diphtheria Toxoid and Tetanus Toxoid Adsorbed (DT BIK®) vaccine.
    Arm type
    Active comparator

    Investigational medicinal product name
    Diphtheria Toxoid and Tetanus Toxoid Adsorbed (DT Biken)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.1 mL, subcutaneous in the central region of deltoid, 1 injection on Day 0.

    Number of subjects in period 1
    SP306 Group DT Biken Group
    Started
    356
    178
    Completed
    355
    178
    Not completed
    1
    0
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SP306 Group
    Reporting group description
    Subjects received 1 dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306, Tdap5) vaccine intramuscularly.

    Reporting group title
    DT Biken Group
    Reporting group description
    Subjects received 1 dose of Diphtheria Toxoid and Tetanus Toxoid Adsorbed (DT BIK®) vaccine.

    Reporting group values
    SP306 Group DT Biken Group Total
    Number of subjects
    356 178 534
    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)
    280 138 418
        Adolescents (12-17 years)
    76 40 116
        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)
    11.2 ± 0.4 11.2 ± 0.4 -
    Gender categorical
    Units: Subjects
        Female
    183 83 266
        Male
    173 95 268

    End points

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    End points reporting groups
    Reporting group title
    SP306 Group
    Reporting group description
    Subjects received 1 dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306, Tdap5) vaccine intramuscularly.

    Reporting group title
    DT Biken Group
    Reporting group description
    Subjects received 1 dose of Diphtheria Toxoid and Tetanus Toxoid Adsorbed (DT BIK®) vaccine.

    Primary: Percentage of Subjects With Diphtheria and Tetanus Post-Vaccination Booster Response Following Vaccination with Either SP306 or DT BIK® Vaccine

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    End point title
    Percentage of Subjects With Diphtheria and Tetanus Post-Vaccination Booster Response Following Vaccination with Either SP306 or DT BIK® Vaccine
    End point description
    Diphtheria booster response was defined as ≥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. A tetanus booster response is 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. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method.
    End point type
    Primary
    End point timeframe
    Day 28 post-vaccination
    End point values
    SP306 Group DT Biken Group
    Number of subjects analysed
    350
    176
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria Booster Response
    99.7
    98.3
        Tetanus Booster Response
    100
    93.8
    Statistical analysis title
    Diphtheria; Non-inferiority (SP306-DT Biken)
    Statistical analysis description
    Non-inferiority comparison of post-vaccination booster response rates between groups for diphtheria.
    Comparison groups
    SP306 Group v DT Biken Group
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    % difference in booster response rates
    Point estimate
    1.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.31
         upper limit
    4.61
    Notes
    [1] - Non-inferiority is supported by the data if the lower bound of the two-sided 95% confidence interval is greater than -10%. The 95% CI of the non-inferiority comparison was estimated by Wilson score method without continuity correction as described by Newcombe. The SP306 vaccine group was non-inferior to the DT Biken vaccine group.
    Statistical analysis title
    Tetanus; Non-inferiority (SP306-DT Biken)
    Statistical analysis description
    Non-inferiority comparison of post-vaccination booster response rates between groups for tetanus.
    Comparison groups
    SP306 Group v DT Biken Group
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    Parameter type
    % difference in booster response rates
    Point estimate
    6.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.32
         upper limit
    10.84
    Notes
    [2] - Non-inferiority is supported by the data if the lower bound of the two-sided 95% confidence interval is greater than -10%. The 95% CI of the non-inferiority comparison was estimated by Wilson score method without continuity correction as described by Newcombe. The SP306 vaccine group was non-inferior to the DT Biken vaccine group.

    Primary: Percentage of Subjects With Seroprotection to Diphtheria and Tetanus Antigens Post-Booster Vaccination With Either SP306 or DT BIK® Vaccine

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    End point title
    Percentage of Subjects With Seroprotection to Diphtheria and Tetanus Antigens Post-Booster Vaccination With Either SP306 or DT BIK® Vaccine
    End point description
    Seroprotection was defined as the proportion of subjects at 28 days post-vaccination with diphtheria and tetanus antitoxin concentration ≥0.1 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method.
    End point type
    Primary
    End point timeframe
    Day 28 post-vaccination
    End point values
    SP306 Group DT Biken Group
    Number of subjects analysed
    350
    176
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria
    100
    99.4
        Tetanus
    100
    100
    Statistical analysis title
    Diphtheria; Non-inferiority (SP306-DT Biken)
    Statistical analysis description
    Non-inferiority comparison of post-vaccination seroprotection rates (≥0.1 IU/mL) between groups for diphtheria.
    Comparison groups
    SP306 Group v DT Biken Group
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    Method
    Parameter type
    % difference in seroprotection rates
    Point estimate
    0.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.61
         upper limit
    3.15
    Notes
    [3] - Non-inferiority is supported by the data if the lower bound of the two-sided 95% confidence interval is greater than -10%. The 95% CI of the non-inferiority comparison was estimated by Wilson score method without continuity correction as described by Newcombe. The SP306 vaccine group was non-inferior to the DT Biken vaccine group.
    Statistical analysis title
    Tetanus; Non-inferiority (SP306-DT Biken)
    Statistical analysis description
    Non-inferiority comparison of post-vaccination seroprotection rates between groups for tetanus.
    Comparison groups
    SP306 Group v DT Biken Group
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [4]
    Method
    Parameter type
    % difference in seroprotection rates
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.09
         upper limit
    2.14
    Notes
    [4] - Non-inferiority is supported by the data if the lower bound of the two-sided 95% confidence interval is greater than -10%. The 95% CI of the non-inferiority comparison was estimated by Wilson score method without continuity correction as described by Newcombe. The SP306 vaccine group was non-inferior to the DT Biken vaccine group.

    Primary: Percentage of Subjects With Pertussis Booster Response Following Vaccination With Either SP306 or DT BIK® Vaccine

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    End point title
    Percentage of Subjects With Pertussis Booster Response Following Vaccination With Either SP306 or DT BIK® Vaccine [5]
    End point description
    Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post-vaccination level ≥4X LLOQ; or a pre-vaccination antibody concentration ≥ 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). Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method.
    End point type
    Primary
    End point timeframe
    Day 28 post-vaccination
    Notes
    [5] - 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
    SP306 Group DT Biken Group
    Number of subjects analysed
    350
    176
    Units: Percentage of subjects
    number (not applicable)
        Pertussis Toxoid
    39.1
    1.1
        Filamentous Hemagglutinin
    95.1
    2.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT BIK® Vaccine

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    End point title
    Percentage of Subjects With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT BIK® Vaccine
    End point description
    Seroprotection was defined as the proportion of subjects with pre-vaccination with diphtheria and tetanus antitoxin concentration ≥ 0.1 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination)
    End point values
    SP306 Group DT Biken Group
    Number of subjects analysed
    350
    176
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria
    46.6
    46.6
        Tetanus
    77.1
    77.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT BIK® Vaccine

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    End point title
    Percentage of Subjects With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT BIK® Vaccine
    End point description
    Seroprotection was defined as the proportion of subjects with diphtheria and tetanus antitoxin concentration level ≥ 0.01 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 post-vaccination
    End point values
    SP306 Group DT Biken Group
    Number of subjects analysed
    350
    176
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria (pre-vaccination)
    97.4
    97.7
        Diphtheria (post-vaccination)
    100
    99.4
        Tetanus (pre-vaccination)
    100
    99.4
        Tetanus (post-vaccination)
    100
    100
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT BIK® Vaccine

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    End point title
    Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT BIK® Vaccine
    End point description
    Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 post-vaccination
    End point values
    SP306 Group DT Biken Group
    Number of subjects analysed
    350
    176
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Diphtheria (pre-vaccination)
    0.1 (0.09 to 0.12)
    0.1 (0.08 to 0.12)
        Diphtheria (post-vaccination)
    8.64 (7.78 to 9.59)
    10.08 (8.29 to 12.26)
        Tetanus (pre-vaccination)
    0.25 (0.22 to 0.27)
    0.24 (0.2 to 0.28)
        Tetanus (post-vaccination)
    26.15 (24.2 to 28.26)
    7.58 (6.75 to 8.52)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT BIK® Vaccine

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    End point title
    Percentage of Subjects with Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT BIK® Vaccine
    End point description
    Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post-vaccination level ≥4X LLOQ; or a pre-vaccination antibody concentration ≥ 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). Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method.
    End point type
    Secondary
    End point timeframe
    Day 28 post-vaccination
    End point values
    SP306 Group DT Biken Group
    Number of subjects analysed
    350
    176
    Units: Percentage of subjects
    number (not applicable)
        Pertactin
    90.3
    0.6
        Fimbriae Types 2 and 3
    94.6
    0.6
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT BIK® Vaccine

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    End point title
    Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT BIK® Vaccine
    End point description
    Pertussis antitoxin concentration levels were assayed by the enzyme-linked immunosorbent assay (ELISA) method.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 post-vaccination
    End point values
    SP306 Group DT Biken Group
    Number of subjects analysed
    350
    176
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Pertussis toxoid (pre-vaccination)
    6.27 (5.59 to 7.03)
    6.15 (5.24 to 7.21)
        Pertussis toxoid (post-vaccination)
    23.83 (21.59 to 26.3)
    6.07 (5.16 to 7.13)
        Filamentous Hemagglutinin (pre-vaccination)
    19.14 (17.01 to 21.55)
    21.55 (18.41 to 25.22)
        Filamentous Hemagglutinin (post-vaccination)
    160.66 (149.49 to 172.66)
    21.16 (18.17 to 24.65)
        Pertactin (pre-vaccination)
    7.02 (6.15 to 8.01)
    8.2 (6.74 to 9.98)
        Pertactin (post-vaccination)
    129.59 (112.15 to 149.73)
    7.94 (6.52 to 9.67)
        Fimbriae (pre-vaccination)
    3.43 (3.12 to 3.76)
    3.68 (3.18 to 4.25)
        Fimbriae (post-vaccination)
    233.01 (198.02 to 274.17)
    3.63 (3.13 to 4.21)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Injection-site and Systemic Reactions Following A Single Booster Dose of SP306 or DT BIK® Vaccine

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    End point title
    Percentage of Subjects Reporting Solicited Injection-site and Systemic Reactions Following A Single Booster Dose of SP306 or DT BIK® Vaccine
    End point description
    Solicited Injection-site: Pain, Erythema, Swelling; Solicited Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection-site: Pain, Significant, prevents daily activity; Erythema and Swelling >100 mm. Grade 3 Systemic reactions: Fever, >39°C; Headache, Malaise, Myalgia, Significant, prevents daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    SP306 Group DT Biken Group
    Number of subjects analysed
    356
    178
    Units: Percentage of subjects
    number (not applicable)
        Any Injection-site reaction
    83.1
    64
        Grade 3 Injection-site reaction
    2.2
    0
        Injection-site Pain
    80.1
    48.3
        Grade 3 Injection-site Pain
    0
    0
        Injection-site Erythema
    20.2
    27.5
        Grade 3 Injection-site Erythema
    1.4
    0
        Injection-site Swelling
    20.2
    22.5
        Grade 3 Injection-site Swelling
    1.4
    0
        Any Solicited systemic reaction
    60.7
    32
        Grade 3 Solicited systemic reaction
    0.8
    0
        Fever
    9.3
    2.2
        Grade 3 Fever
    0.6
    0
        Headache
    20.5
    12.4
        Grade 3 Headache
    0.3
    0
        Malaise
    23.9
    13.5
        Grade 3 Malaise
    0.3
    0
        Myalgia
    44.1
    20.2
        Grade 3 Myalgia
    0.3
    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 Day 28 post-vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    SP306 Group
    Reporting group description
    Subjects received 1 dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306, Tdap5) vaccine intramuscularly.

    Reporting group title
    DT Biken Group
    Reporting group description
    Subjects received 1 dose of Diphtheria Toxoid and Tetanus Toxoid Adsorbed (DT Biken) vaccine.

    Serious adverse events
    SP306 Group DT Biken Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 356 (0.00%)
    0 / 178 (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
    SP306 Group DT Biken Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 356 (5.34%)
    12 / 178 (6.74%)
    General disorders and administration site conditions
    Injection site pruritus
         subjects affected / exposed
    16 / 356 (4.49%)
    11 / 178 (6.18%)
         occurrences all number
    16
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    18 / 356 (5.06%)
    10 / 178 (5.62%)
         occurrences all number
    19
    12

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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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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