NCT01091298已完成1 期
Phase I Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Tolerability of a Single Administration (10e6.25 FFU of Each Constituent Serotype Per 0.5 ml) of Live Attenuated Tetravalent (G1-G4) Bovine-human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Adult Males
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Severity and causality of all Adverse Events following the dose of vaccine/placebo
研究概览
简要总结
This is a Phase I study to evaluate the safety and tolerability of the tetravalent rota virus vaccine in healthy Indian adult male volunteers administered a single dose of the vaccine at the highest possible viral concentration in 0.5 mL of vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Indian adult male volunteers.
- •No apparent signs or symptoms of ill health.
- •Properly informed about the study and having signed the informed consent form (ICF). In case of the volunteer being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the ICF;
- •Subject available for the entire period of the study and reachable by study staff for post-vaccination follow-up.
排除标准
- •Known or suspected impairment of immunological function;
- •Known hypersensitivity to any component of the rotavirus vaccine;
- •Fever, with axillary temperature ≥38.1oC (≥100.5oF); measured by study staff.
- •History of chronic diarrhea;
- •Clinical evidence of active gastrointestinal illness;
- •Receipt of any intramuscular (IM), oral, or intravenous (IV) corticosteroid treatment in the past 30 days
- •Subjects suspected to be HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) positive from the available clinical history
- •Prior receipt of a blood transfusion or blood products, including immunoglobulins;
- •Any subject who cannot be adequately followed for safety;
- •Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •Subject unable to maintain diary card
结局指标
主要结局
Severity and causality of all Adverse Events following the dose of vaccine/placebo
时间窗: upto 10 days following administration of vaccine/placebo
The frequency, severity and causality of all solicited and unsolicited adverse events following administration of a single dose of the vaccine as compared to placebo
次要结局
- The frequency and the percentage change, as compared to baseline, in the protocol defined laboratory parameters following the single dose of Vaccine/placebo(Upto 10 days following administration of vaccine/placebo)
研究者
研究点 (2)
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