Safety and immunogenicity study of GSK Biologicals’ candidate tuberculosis vaccine (692342) when administered to healthy infants.

Active, not recruiting

• Conditions: Healthy volunteers (evaluation of safety and reactogenicity of TB vaccine when administered in healthy infants); Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-004380-44-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-20
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Active
• Sex: All
• Target Recruitment: 301

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 301
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
•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 in-crease the risk of having an adverse outcome from par-ticipation in the trial.
•Acute disease and/or fever at the time of enrolment:
-fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting.
-Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
•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 EPI' Cohort only: Previous vaccination with diphtheria, tetanus, pertussis, H. 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. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•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 defined as weight-for-age Z-score < -3 SD*
•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.
* World Health Organisation (WHO) Global Database on Child Growth and Malnutrition, Geneva, 1997.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified