EUCTR2012-004380-44-Outside-EU/EEA进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 301
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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