Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: GSK's investigational vaccine 692342; Placebo
Intervention description: Intramuscular injection, 2 doses; Intramuscular injection, 2 doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tuberculosis vaccine

Summary:

      This observer blind study will assess the safety and immunogenicity of GSK Biologicals'
      investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a
      TB-endemic region.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and their parent(s)/ legal
             guardian(s) can and will comply with the requirements of the protocol.

          -  A male or female between, and including, 13 and 17 years of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the subject's parent(s) or legal guardian(s).

          -  Written informed assent obtained from the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Seronegative for HIV-1.

          -  No history of TB disease.

          -  No active pulmonary disease on chest X-ray.

          -  Availability for the duration of the immunisation and follow-up period, with the
             family not planning to move away from the study area within the next year.

          -  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
             is abstinent, has practiced 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 vaccination period and for 2 months
             after completion of the vaccination series.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the first dose of study vaccine, or planned use
             during the study period.

          -  Administration of a registered live vaccine not foreseen by the study within 30 days
             preceding the first dose of study vaccine and administration of a registered
             inactivated vaccine within 14 days preceding the first dose of study vaccine.

          -  History of previous administration of investigational Mycobacterium tuberculosis
             vaccines.

          -  History of previous exposure to components of the investigational vaccine.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose.

          -  Any condition or illness (acute, chronic or history) or medication, which in the
             opinion of the investigator might interfere with the evaluation of the safety or
             immunogenicity of the study vaccine.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first dose of vaccine, or planned administration during the study.

          -  Planned participation or participation in another experimental clinical study during
             the study period.

          -  A family history of congenital or hereditary immunodeficiency.

          -  Any chronic drug therapy to be continued during the study period, with the exception
             of vitamins and/or dietary supplements, birth control pills, anti-histamines for
             seasonal allergies and Specific Serotonin Reuptake Inhibitors (SSRIs).

          -  History of allergic reactions (significant IgE-mediated events) or anaphylaxis to any
             vaccine.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the study vaccine.

          -  Pregnant female, lactating female or female planning to become pregnant or discontinue
             contraceptive precautions.

          -  Drug and/or alcohol abuse