Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children
Condition: Diphtheria; Tetanus; Acellular Pertussis
MeSH terms: Diphtheria
Intervention: Boostrix™
Intervention description: Single-dose administered intramuscularly in the deltoid region of non-dominant arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 302.0
Sex: All
Minimum age: 6 Years
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vietnam; Children; Reactogenicity; BoostrixTM; Safety; dTpa; Booster; Healthy

Summary:

      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.
    

Eligibility 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.