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    Clinical Trial Results:
    Clinical Safety Study of the Tdap Combined Vaccine (ADACEL) as a Booster Dose in Healthy Adults and Children in China

    Summary
    EudraCT number
    		 2015-003914-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 Oct 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    Td527
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01933776
    WHO universal trial number (UTN)
    		 U1111-1127-7738
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur China
    Sponsor organisation address
    6th floor, No. 112 Jian Guo Lu, Chaoyang District, Beijing, China, 100022
    Public contact
    Director, Medical Affairs, Sanofi Pasteur China, 86 10-6568 5588 ex 7312, Jean-Denis.SHU@sanofipasteur.com
    Scientific contact
    Director, Medical Affairs, Sanofi Pasteur China, 86 10-6568 5588 ex 7312, 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
    20 Nov 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety in terms of occurrence of serious adverse reactions and Grade 3 adverse reactions after administration of Sanofi Pasteur’s Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children.
    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
    27 Aug 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: 40
    Worldwide total number of subjects
    40
    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)
    20
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    20
    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 27 August 2013 through 08 October 2013 at 1 clinic center in China.

    Pre-assignment
    Screening details
    		 A total of 40 subjects who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated in this 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
    Are arms mutually exclusive
    Yes

    Arm title
    		 ADACEL™ Vaccine Group 1 (Adults)
    Arm description
    		 Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed -Tdap (Adacel™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5, intramuscular in the right deltoid, 1 injection of ADACEL on Day 0 (Visit 1).

    Arm title
    		 ADACEL™ Vaccine Group 2 (Children)
    Arm description
    		 Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACEL™).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed -Tdap (Adacel™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5, intramuscular in the right deltoid, 1 injection of ADACEL on Day 0 (Visit 1).

    Number of subjects in period 1
    		ADACEL™ Vaccine Group 1 (Adults) ADACEL™ Vaccine Group 2 (Children)
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ADACEL™ Vaccine Group 1 (Adults)
    Reporting group description
    		 Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™).

    Reporting group title
    ADACEL™ Vaccine Group 2 (Children)
    Reporting group description
    		 Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACEL™).

    Reporting group values
    		 ADACEL™ Vaccine Group 1 (Adults) ADACEL™ Vaccine Group 2 (Children) Total
    Number of subjects
    		 20 20 40
    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 20 20
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 20 0 20
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.2 ± 14.4 5.8 ± 1.1 -
    Gender categorical
    Units: Subjects
        Female
    		 10 14 24
        Male
    		 10 6 16

    End points

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    End points reporting groups
    Reporting group title
    ADACEL™ Vaccine Group 1 (Adults)
    Reporting group description
    		 Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™).

    Reporting group title
    ADACEL™ Vaccine Group 2 (Children)
    Reporting group description
    		 Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACEL™).

    Primary: Number of Subjects Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of ADACEL™ Vaccine

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    End point title
    		 Number of Subjects Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of ADACEL™ Vaccine [1]
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, Incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling, > 30 mm; Fever (Temperature) > 39°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
    End point type
    Primary
    End point timeframe
    Day 0 up to 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 1 (Adults) ADACEL™ Vaccine Group 2 (Children)
    Number of subjects analysed
    20
    20
    Units: Number of subjects
    number (not applicable)
        Grade 3 Injection site Pain
    0
    0
        Grade 3 Injection site Erythema
    0
    3
        Grade 3 Injection site Swelling
    0
    3
        Grade 3 Fever
    0
    0
        Grade 3 Headache
    0
    0
        Grade 3 Malaise
    0
    0
        Grade 3 Myalgia
    0
    0
        Serious adverse events
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following A Single Booster Dose of Adacel™ Vaccine

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    End point title
    		 Number of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following A Single Booster Dose of Adacel™ Vaccine
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, Incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling, > 30 mm; Fever (Temperature) > 39°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    		 ADACEL™ Vaccine Group 1 (Adults) ADACEL™ Vaccine Group 2 (Children)
    Number of subjects analysed
    20
    20
    Units: Number of subjects
    number (not applicable)
        Injection site Pain
    6
    9
        Grade 3 Injection site Pain
    0
    0
        Injection site Erythema
    1
    9
        Grade 3 Injection site Erythema
    0
    3
        Injection site Swelling
    3
    9
        Grade 3 Injection site Swelling
    0
    3
        Fever
    0
    3
        Grade 3 Fever
    0
    0
        Headache
    1
    1
        Grade 3 Headache
    0
    0
        Malaise
    0
    0
        Grade 3 Malaise
    0
    0
        Myalgia
    1
    1
        Grade 3 Myalgia
    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 (post-vaccination) up to Day 28 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    ADACEL™ Vaccine Group 1 (Adults)
    Reporting group description
    		 Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™).

    Reporting group title
    ADACEL™ Vaccine Group 2 (Children)
    Reporting group description
    		 Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACEL™).

    Serious adverse events
    		 ADACEL™ Vaccine Group 1 (Adults) ADACEL™ Vaccine Group 2 (Children)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (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 1 (Adults) ADACEL™ Vaccine Group 2 (Children)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 20 (30.00%)
    9 / 20 (45.00%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    3
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    9 / 20 (45.00%)
         occurrences all number
    1
    9
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 20 (30.00%)
    9 / 20 (45.00%)
         occurrences all number
    6
    9
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 20 (15.00%)
    9 / 20 (45.00%)
         occurrences all number
    3
    9
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1

    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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