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    Clinical Trial Results:
    Immunogenicity and Safety of Sanofi Pasteur’s Tdap Combined Vaccine (ADACEL) as a Booster Dose, versus Local DT Vaccine in Healthy Children or versus Local Td Vaccine in Healthy Adolescents and Adults in China

    Summary
    EudraCT number
    2015-003941-24
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    07 Jan 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Apr 2016
    First version publication date
    24 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Td528
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01993173
    WHO universal trial number (UTN)
    U1111-1127-7835
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Limited, China
    Sponsor organisation address
    6th Floor, No. 112 Jian Guo Lu, Chaoyang District, Beijing, China, 100022
    Public contact
    Director, Clinical Development, Sanofi Pasteur Limited, China, 86 10 6563 8188, Jean-denis.shu@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur Limited, China, 86 10 6563 8188, Jean-denis.shu@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
    24 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe diphtheria and tetanus seroprotection rates and pertussis booster response rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups), local DT vaccine (in children), and local Td vaccine (in adolescents and adults)
    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
    All subjects enrolled in the Td528 study had previously completed primary series and fourth dose of diphtheria, tetanus, and pertussis (DTP) vaccine.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    18 Nov 2013
    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
    China: 1439
    Worldwide total number of subjects
    1439
    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)
    719
    Adolescents (12-17 years)
    141
    Adults (18-64 years)
    579
    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 18 November 2013 to 07 December 2013 at 1 clinic center in China.

    Pre-assignment
    Screening details
    A total of 1440 subjects who met all inclusion and none of the exclusion criteria were randomized, 1439 subjects 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
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    This study was conducted in an observer-blind manner. The Investigator, and blinded staff in charge of safety assessment, did not know which vaccine was administered. Subjects/parents also remained blinded and were unaware of the vaccine assignment. To maintain the blind, the vaccine was prepared in a separate room as well as the safety assessment. In the event of an emergency, i.e., serious adverse event, the code could be broken by the Investigator as described in the code-breaking procedures.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ADACEL 4-11 Years
    Arm description
    Subjects 4 to 11 years of age received a single booster dose of ADACEL (Tdap 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 single booster dose on Day 0.

    Arm title
    ADACEL 12-64 Years
    Arm description
    Subjects 12 to 64 years of age received a single booster dose of ADACEL (Tdap 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 single booster dose on Day 0.

    Arm title
    Local DT 4-11 Years
    Arm description
    Subjects 4-11 years of age received a single booster dose of local DT vaccine.
    Arm type
    Active comparator

    Investigational medicinal product name
    DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the deltoid, 1 single booster dose on Day 0.

    Arm title
    Local Td 12-64 Years
    Arm description
    Subjects 12-64 years of age received a single booster dose of local Td vaccine.
    Arm type
    Active comparator

    Investigational medicinal product name
    Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the deltoid, 1 single booster dose on Day 0.

    Number of subjects in period 1
    ADACEL 4-11 Years ADACEL 12-64 Years Local DT 4-11 Years Local Td 12-64 Years
    Started
    359
    362
    360
    358
    Completed
    359
    362
    360
    358

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ADACEL 4-11 Years
    Reporting group description
    Subjects 4 to 11 years of age received a single booster dose of ADACEL (Tdap vaccine).

    Reporting group title
    ADACEL 12-64 Years
    Reporting group description
    Subjects 12 to 64 years of age received a single booster dose of ADACEL (Tdap vaccine).

    Reporting group title
    Local DT 4-11 Years
    Reporting group description
    Subjects 4-11 years of age received a single booster dose of local DT vaccine.

    Reporting group title
    Local Td 12-64 Years
    Reporting group description
    Subjects 12-64 years of age received a single booster dose of local Td vaccine.

    Reporting group values
    ADACEL 4-11 Years ADACEL 12-64 Years Local DT 4-11 Years Local Td 12-64 Years Total
    Number of subjects
    359 362 360 358 1439
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    359 0 360 0 719
        Adolescents (12-17 years)
    0 71 0 70 141
        Adults (18-64 years)
    0 291 0 288 579
        From 65-84 years
    0 0 0 0 0
        85 years and over
    0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    8.45 ± 1.78 39.3 ± 16.2 8.52 ± 1.78 38.9 ± 16.2 -
    Gender categorical
    Units: Subjects
        Female
    152 216 152 217 737
        Male
    207 146 208 141 702

    End points

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    End points reporting groups
    Reporting group title
    ADACEL 4-11 Years
    Reporting group description
    Subjects 4 to 11 years of age received a single booster dose of ADACEL (Tdap vaccine).

    Reporting group title
    ADACEL 12-64 Years
    Reporting group description
    Subjects 12 to 64 years of age received a single booster dose of ADACEL (Tdap vaccine).

    Reporting group title
    Local DT 4-11 Years
    Reporting group description
    Subjects 4-11 years of age received a single booster dose of local DT vaccine.

    Reporting group title
    Local Td 12-64 Years
    Reporting group description
    Subjects 12-64 years of age received a single booster dose of local Td vaccine.

    Primary: Percentage of Subjects with Diphtheria and Tetanus Seroprotection and Pertussis Booster Response One Month After Booster Vaccination with ADACEL or Local DT or Local Td Vaccine

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    End point title
    Percentage of Subjects with Diphtheria and Tetanus Seroprotection and Pertussis Booster Response One Month After Booster Vaccination with ADACEL or Local DT or Local Td Vaccine [1]
    End point description
    Diphtheria and Tetanus antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as Anti-Diphtheria or Anti-Tetanus antibody concentrations ≥ 0.1 IU/mL. Pertussis (Pertussis Toxoid, Filamentous hemagglutinin, Pertactin, and Fimbriae Types 2 and 3) booster response was defined as subjects with pre-vaccination antibody concentrations < lower limit of quantitation (LLOQ) if post-vaccination levels ≥ 4 x LLOQ, for subjects with pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ if post-/pre-vaccination antibody concentrations ratio ≥ 4, for subjects with pre-vaccination antibody concentrations ≥ 4 x LLOQ if post-/pre-vaccination antibody concentrations ratio ≥ 2.
    End point type
    Primary
    End point timeframe
    1 month post-booster 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 4-11 Years ADACEL 12-64 Years Local DT 4-11 Years Local Td 12-64 Years
    Number of subjects analysed
    354
    362
    354
    357
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria seroprotection
    99.7
    99.2
    100
    100
        Tetanus seroprotection
    100
    100
    100
    100
        Pertussis Toxoid booster response
    89.5
    93.4
    28.8
    43.7
        Filamentous hemagglutinin booster response
    99.2
    94.2
    59.6
    67.2
        Pertactin booster response
    80.2
    89
    44.4
    9
        Fimbriae Types 2 and 3 booster response
    98.6
    95.6
    29.7
    9.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions After Booster Vaccination with ADACEL or Local DT or Local Td Vaccine

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    End point title
    Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions After Booster Vaccination with ADACEL or Local DT or Local Td Vaccine
    End point description
    Solicited Injection site reactions: Pain, Erythema, and Swelling. Solicited Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 Solicited Injection site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, > 30 mm. Grade 3 Solicited Systemic reactions: Fever, > 39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-booster vaccination
    End point values
    ADACEL 4-11 Years ADACEL 12-64 Years Local DT 4-11 Years Local Td 12-64 Years
    Number of subjects analysed
    359
    362
    360
    358
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Pain
    42.6
    44.5
    35.6
    39.4
        Grade 3 Injection site Pain
    0.3
    0
    0.6
    0
        Any Injection site Erythema
    12.5
    10.2
    9.4
    7
        Grade 3 Injection site Erythema
    1.1
    0.6
    0
    0.3
        Any Injection site Swelling
    11.7
    9.9
    8.9
    7.3
        Grade 3 Injection site Swelling
    3.1
    1.1
    0.3
    0.8
        Any Fever
    9.7
    6.6
    11.9
    6.4
        Grade 3 Fever
    0
    0
    0
    0
        Any Headache
    6.7
    8.6
    6.7
    6.4
        Grade 3 Headache
    0
    0.3
    0
    0.3
        Any Malaise
    15
    16.3
    16.1
    14
        Grade 3 Malaise
    0
    0.3
    0
    0
        Any Myalgia
    18.7
    19.1
    15.6
    14.5
        Grade 3 Myalgia
    0.6
    0.3
    0
    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 1 month post-booster vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    ADACEL 4-11 Years
    Reporting group description
    Subjects 4 to 11 years of age received a single booster dose of ADACEL (Tdap vaccine).

    Reporting group title
    ADACEL 12-64 Years
    Reporting group description
    Subjects 12 to 64 years of age received a single booster dose of ADACEL (Tdap vaccine).

    Reporting group title
    Local DT 4-11 Years
    Reporting group description
    Subjects 4-11 years of age received a single booster dose of local DT vaccine.

    Reporting group title
    Local Td 12-64 Years
    Reporting group description
    Subjects 12-64 years of age received a single booster dose of local Td vaccine.

    Serious adverse events
    ADACEL 4-11 Years ADACEL 12-64 Years Local DT 4-11 Years Local Td 12-64 Years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 362 (0.00%)
    0 / 360 (0.00%)
    0 / 358 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    ADACEL 4-11 Years ADACEL 12-64 Years Local DT 4-11 Years Local Td 12-64 Years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    153 / 359 (42.62%)
    161 / 362 (44.48%)
    128 / 360 (35.56%)
    141 / 358 (39.39%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    24 / 359 (6.69%)
    31 / 362 (8.56%)
    24 / 360 (6.67%)
    23 / 358 (6.42%)
         occurrences all number
    24
    31
    24
    23
    General disorders and administration site conditions
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    153 / 359 (42.62%)
    161 / 362 (44.48%)
    128 / 360 (35.56%)
    141 / 358 (39.39%)
         occurrences all number
    153
    161
    128
    141
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    45 / 359 (12.53%)
    37 / 362 (10.22%)
    34 / 360 (9.44%)
    25 / 358 (6.98%)
         occurrences all number
    45
    37
    34
    25
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    42 / 359 (11.70%)
    36 / 362 (9.94%)
    32 / 360 (8.89%)
    26 / 358 (7.26%)
         occurrences all number
    42
    36
    32
    26
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    35 / 359 (9.75%)
    24 / 362 (6.63%)
    43 / 360 (11.94%)
    23 / 358 (6.42%)
         occurrences all number
    35
    24
    43
    23
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    54 / 359 (15.04%)
    59 / 362 (16.30%)
    58 / 360 (16.11%)
    50 / 358 (13.97%)
         occurrences all number
    54
    59
    58
    50
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    67 / 359 (18.66%)
    69 / 362 (19.06%)
    56 / 360 (15.56%)
    52 / 358 (14.53%)
         occurrences all number
    67
    69
    56
    52

    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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