CTRI/2021/06/034374已完成3 期
A Prospective, Randomized, Double Blind, Placebo controlled Phase III, MulticenterStudy to evaluate the Immunogenicity and Safety of Recombinant Hepatitis E Vaccine inHealthy Adults & Adolescents.
rihk Pharmaceutical Private Limited Subsidiary of Ureka Hong Kong Limited0 个研究点目标入组 190 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
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
- •The subjects must meet all of the following criteria:
- •1.Indian adults and adolescents of either gender, aged 16-65 years (both ends inclusive) who are seronegative for Anti-HEV antibody (as per the cut-off values specified in kit brochure)
- •2.Subjects who are apparently healthy or having a clinically stable medical condition/disorder that would not interfere with evaluation of study vaccine
- •3.Subjects who would be available during the entire study period of 7 months
- •4.Subjects who agree to comply with trial requirements and are willing to provide written informed consent and assent form wherever applicable (participant of >16 to <18 years age)
排除标准
- •The Subjects must not meet any of the following criteria:
- •1.History of hypersensitivity to Investigational Products or their constituents, kanamycin or any other aminoglycoside.
- •2.History of administration of any other vaccine or immunoglobulin in past 1 month or planned immunization of any other vaccine in next 7 months.
- •3.Clinical or laboratory evidence of ongoing viral hepatitis
- •4.History or evidence of uncontrolled epilepsy or any progressive neurological disorder in the subject or family.
- •5.History or evidence of thrombocytopenia, blood coagulation abnormality or concomitant administration of any anticoagulant drugs.
- •6.History or evidence of any congenital or acquired immunodeficiency viz. HIV infection and/or concomitant administration of immunosuppressive drugs.
- •7.History or evidence of acute infections, acute flare of chronic infections or fever at the time of administration of vaccine.
- •8.History or evidence of any significant cardiovascular, hepatic, renal, neurological or neoplastic disorder which preludes participation of subject into the trial as per investigator discretion.
- •9.Subject who is pregnant as confirmed by positive UPT, or lactating female.
- •10.Female of child bearing potential not willing to practice acceptable method of contraception during study period
- •11.History or evidence of any chronic alcohol abuse / chronic tobacco or drug abuse.
- •12.Subject who has participated in any other clinical study in past 3 months.
- •13.Subject judged ineligible for the vaccination by the investigator for any other reason.
研究者
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