CTRI/2011/09/002033已完成1 期
A Phase I clinical trial to assess safety and immune response of Trivalent, Live Attenuated Seasonal Influenza vaccine of SIIL in Adults.
Serum Institute of India Ltd Pune India1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年9月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety- solicited, unsolicited, serious adverse events and new onset chronic medical conditions
研究概览
简要总结
This is a Phase I,observer-blind, randomized, active-controlled, parallel group, clinical studyto evaluate the safety and immunogenicity of SII LAIV in 40 adults. There will be two study groups. Subjects in each age group willreceive single dose of 0.5 ml of formulationA or B of SII LAIV on Day 0. Vitalswill be assessed during the screening and 30 minutes after vaccination. Allthese subjects will be followed for 42 days for safety and immunogenecity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- All
入选标准
- •Normal healthy subjects of 18-49 years age.
排除标准
- •Confirmed/suspected influenza infection or any influenza vaccination.
- •Have a known allergy to eggs.
- •Pregnancy and breastfeeding women
- •Subject participating in other clinical trial
- •Altered immune status.
- •Acute febrile illness or acute infectious disease.
- •Any nasal pathology.
- •History of allergic reaction.
- •History of serious chronic illness.
- •Guillain-Barré Syndrome.
结局指标
主要结局
Safety- solicited, unsolicited, serious adverse events and new onset chronic medical conditions
时间窗: Day 0,Day 7, Day 21 and Day 42
次要结局
- Seroconversion(On day 7 & day 21)
研究者
研究点 (1)
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