safety and immunogenicity study of a candidate tuberculosis vaccine in healthy infants

Conditions: Tuberculosis

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.

Keywords: tuberculosis vaccine