Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: GSK's investigational vaccine 692342; Tritanrix™ HB+Hib; Prevnar™; Polio Sabin™; Menjugate™
Intervention description: Intramuscular, 1 or 2 doses; Intramuscular, 3 doses; Intramuscular, 3 doses; Oral, 3 doses; Intramuscular, 3 doses
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 301.0
Sex: All
Minimum age: 2 Months
Maximum age: 7 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tuberculosis vaccine

Summary:

      This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals'
      candidate tuberculosis vaccine (692342) when administered concomitantly with or after the
      Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and
      including 2 and 7 months, living in a tuberculosis endemic region.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects who the investigator believes that their parent(s)/ Legally
             Acceptable Representative (LAR(s)) can and will comply with the requirements of the
             protocol.

          -  Written or oral, signed or thumb-printed and witnessed informed consent obtained from
             the subject's parent(s)/LAR(s).

          -  Subjects who received their birth dose of Bacille Calmette Guerrin.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        For the 'Outside Expanded Programme on Immunisation' cohort:

          -  Must have documented evidence that he/she has completed the primary Expanded Programme
             on Immunisation regimen at least 1 month prior to planned vaccination with
             investigational vaccination regimen.

          -  Aged between 5 and 7 months at the time of the first study vaccination.

        For the 'Within EPI' cohort:

          -  Must have received the birth dose of Bacille Calmette Guerrin, oral polio vaccine and
             Hepatitis B vaccine but NO further Expanded Programme on Immunisation vaccines.

          -  Aged between 2 and 4 months at the time of the first study vaccination with
             diphtheria, tetanus, whole cell pertussis/ Haemophilus influenzae type b vaccine +
             pneumococcal conjugate vaccine + oral polio vaccine.

        Exclusion Criteria:

          -  Child in care

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             abnormality, as determined by physical examination and/or laboratory screening tests.

          -  Laboratory screening tests out of range, which in the investigator's opinion affects
             the ability of the child to take part in the study.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  A family history of congenital or hereditary immunodeficiency.

          -  Major congenital defects.

          -  History of any neurological disorders or seizures.

          -  Any condition or illness or medication, which in the opinion of the investigator might
             interfere with the evaluation of the safety or immunogenicity of the study vaccine.

          -  Any other findings that the investigator feels would increase the risk of having an
             adverse outcome from participation in the trial.

          -  Acute disease and/or fever at the time of enrolment.

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  For the 'Within Expanded Programme on Immunisation' Cohort only: Previous vaccination
             with diphtheria, tetanus, pertussis, Haemophilus influenzae type b and pneumococcal
             conjugate vaccine.

          -  History of previous administration of experimental Mycobacterium tuberculosis
             vaccines.

          -  Administration of immunoglobulins, blood transfusions and/or other blood products
             since birth to the first dose of study vaccine or planned administration during the
             study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose.

          -  Planned participation or 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.

          -  Any chronic drug therapy to be continued during the study period, with the exception
             of vitamins and/or dietary supplements

          -  History of allergic reactions or anaphylaxis to any vaccine.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the study vaccines.

          -  Severe malnutrition at screening defined as weight-for-age Z-score < -3 standard
             deviation.

          -  Children will not be enrolled if any maternal, obstetrical or neonatal event that has
             occurred might, in the judgment of the investigator, result in increased
             neonatal/infant morbidity.