Last updated: 07/17/2024 16:41:56

Safety of a booster dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ vaccine in healthy Vietnamese children

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GSK study ID
115739
See study documents
Clinicaltrials.gov ID
NCT01988857
See results summary
EudraCT ID
2013-003859-37
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Safety and reactogenicity of GSK Biologicals’ dTpa vaccine (Boostrix™) in healthy Vietnamese children
Trial description: This study will evaluate the safety and reactogenicity of GSK Biologicals’ combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when given as a single injection to 6-10 year old children. Data that are available globally on the age group from four to six years of age will be used to bridge the age gap in this study and aid in the registration of the vaccine for children from the age of four years.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Numbers of subjects with any and Grade 3 solicited local symptoms

Timeframe: Within 4 days (Days 0-3) post vaccination period

Number of subjects with any, grade 3 and related solicited general symptoms

Timeframe: Within 4 days (Days 0-3) post vaccination period

Number of subjects with unsolicited adverse events (AEs)

Timeframe: Within 31 days (Days 0-30) post vaccination period

Number of subjects with serious adverse events (SAEs)

Timeframe: During the entire study period (From Day 0 to Day 30)

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Boostrix™
    • Enrollment:
    302
    Primary completion date:
    2014-10-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diphtheria, Tetanus, acellular pertussis, Diphtheria-Tetanus-acellular Pertussis Vaccines
    Product
    SB263855
    Collaborators
    Not applicable
    Study date(s)
    February 2014 to May 2014
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 10 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
    • A male or female between, and including, 6 and 10 years of age at the time of the vaccination.
    • Child in care.
    • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.

      • A male or female between, and including, 6 and 10 years of age at the time of the vaccination.
      • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
      • Written informed assent to be obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s), as required by local regulations.
      • Healthy subjects as established by medical history and clinical examination before entering into the study.
      • Subjects who have previously completed their routine vaccinations against diphtheria, tetanus and pertussis diseases according to the local recommended vaccination schedule at that time and have not received the vaccine in the last two years prior to study dose administration.
      • Female subjects of non-childbearing potential may be enrolled in the study.
      • Female subjects of childbearing potential may be enrolled in the study, if the subject:
    • has practiced abstinence or adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
    Exclusion criteria:

      Child in care.

      • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
      • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. Inhaled and topical steroids are allowed.
      • Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccine dose, or planned administration during the study period.
      • Administration of immunoglobulins and/or any blood products within the three months preceding Visit 1 or planned administration during the study period.
      • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
      • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
      • A history of previous or intercurrent diphtheria, tetanus or pertussis disease.
      • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
      • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
      • Major congenital defects or serious chronic illness.
      • Acute disease and/or fever at the time of enrollment.
      • Pregnant or lactating female.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Hanoi, Vietnam, 084
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2014-10-05
    Actual study completion date
    2014-10-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    IPD for this study will be made available via the Clinical Study Data Request site.
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