EUCTR2012-004380-44-Outside-EU/EEA
Active, not recruiting
Not Applicable
A Phase II, open-label, randomised controlled study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ candidate tuberculosis (TB) vaccine (M72/AS01E) when administered intramuscularly according to different immunisation schedules to healthy infants, living in a TB-endemic region. - TUBERCULOSIS-013 PRI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy volunteers (evaluation of safety and reactogenicity of TB vaccine when administered in healthy infants)
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 301
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female 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.
- •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 BCG.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •For the 'Outside EPI' cohort:
- •Must have documented evidence that he/she has completed the primary EPI regimen at least 1 month prior to planned vaccination with M72/AS01E.
- •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 BCG, OPV and Hepatitis B vaccine but NO further EPI vaccines.
- •Aged between 2 and 4 months at the time of the first study vaccination with DTPwHepB/Hib \+ PCV\+ OPV.
Exclusion Criteria
- •Child in care
- •Acute or chronic, clinically significant pulmonary, cardio\-vascular, 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, specifically:
- •\-Alanine aminotransferase (ALT) above acceptable limit
- •\-Creatinine above acceptable limit
- •\-Haemoglobin below acceptable limit
- •\-Platelet count below acceptable limit
- •\-Total white cell count below acceptable limit
- •Any confirmed or suspected immunosuppressive or im\-munodeficient condition, based on medical history and physical examination.
- •A family history of congenital or hereditary immunodefi\-ciency.
Outcomes
Primary Outcomes
Not specified
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