CTRI/2017/10/010104已完成2/3 期
A Phase II/III, Multicenter, Open-Label, Randomized Study of Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) To Evaluate Lot-To-Lot Consistency and to Compare Non-Inferiority with ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India
适应症
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 9
- 主要终点
- •To demonstrate non-inferiority in the immunogenicity of LBRV-PV as compared with ROTASIIL (lyophilized BRV-PV) in infants.
研究概览
简要总结
The study is designed as a phase II/III, open-label, multicenter,randomized, active controlled trial with four groups of infants (n=375 pergroup) receiving one of three different lots of LBRV-PV or ROTASIIL, to compareimmunogenicity of the two formulations and to assess LBRV-PV’s productionconsistency. Three doses of LBRV-PV / ROTASIIL will be administered 4 weeksapart, with the first administration given at 6-8 weeks (42-56 days, both inclusive) of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 42.00 Day(s) 至 56.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Healthy infants as established by medical history and clinical examination before entering the study.
- •2.Age: 6-8 weeks at the time of enrollment.
- •3.Parental ability and willingness to provide informed consent.
- •4.Parent who intends to remain in the area with the child during the study period.
排除标准
- •1.Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
- •2.Presence of fever on the day of enrollment (temporary exclusion).
- •3.Presence of acute disease at the time of enrollment (temporary exclusion).
- •4.Concurrent participation in another clinical trial at any point throughout the entire timeframe for this study.
结局指标
主要结局
•To demonstrate non-inferiority in the immunogenicity of LBRV-PV as compared with ROTASIIL (lyophilized BRV-PV) in infants.
时间窗: 28 days post dose 3
次要结局
- •To evaluate the safety of LBRV-PV in terms of immediate post-vaccination events, solicited reactions, unsolicited adverse events and serious adverse events, including monitoring for intussusception.(Throughout the study period)
研究者
研究点 (9)
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