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

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.

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.