CTRI/2019/01/017026进行中（未招募）3 期
A Phase III, Randomized, Double-blind, three arm Placebo controlled Trial to Evaluate the Efficacy and Safety of two vaccines VPM1002 and Immuvac in Preventing Tuberculosis (TB) in Healthy Household Contacts of Newly Diagnosed Sputum Positive Pulmonary TB Patients.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 12,721
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •i.Healthy household contacts age >= 6 years at the time of enrollment.
- •ii.No evidence of active TB disease during screening â?? Normal chest radiograph with no abnormalities and no bacteriological positivity by smear testing for M.tb
- •iii.Female participants who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 4 months post-vaccination.
- •iv.The participant must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.
- •v.Participant agrees to stay in contact with the study site for the duration of the study, and provide updated and an alternate contact information.
- •vi.Has general good health, as confirmed through medical history and medical evaluation (which includes physical examination and laboratory tests).
排除标准
- •i.Any chronic febrile illness with oral temperature > 100°F on the day of randomization.
- •ii.Prior or present anti-TB treatment
- •iii.Any laboratory abnormalities (haematological and biochemical), at the time of screening, which is of clinical significance as determined by the Investigator.
- •iv.Pregnant and / or lactating female participants.
- •v.Presence of any illness requiring short hospital referral (temporary exclusion).
- •vi.Reactive serology for HIV.
- •vii.Any confirmed or suspected immunodeficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency.
- •viii.History of chronic renal failure/dialysis, silicosis, gastrectomy, jejunoileal bypass, solid organ transplantation such as renal or cardiac transplants, carcinoma of the head and neck, and disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely the volunteer will comply with the protocol as determined by the local investigator.
- •ix.History of previous administration of experimental MTB vaccines.
- •x.History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study vaccination, or planned future administrations during the study period. Participants on inhaled/topical steroids may be permitted to participate in the study.
- •xi.Participation in any clinical trial within 3 months prior to and/or planned concurrent participation in another interventional clinical trial at any point throughout the entire timeframe for this study.
- •xii.History of allergic reactions or anaphylaxis to any vaccine or component of the vaccine.
- •xiii.Presence of any severe systemic/autoimmune disorders as determined by medical history and / or physical examination/ or lab investigations at the time of screening, which in the judgment of the Investigator would compromise the participantâ??s health or is likely to result in nonconformance to the protocol or a participantâ??s ability to give written informed consent/assent.
研究者
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