A Double-Blind, Randomized, Placebo-Controlled, Safety and Tolerability Study of Live Pentavalent Human-Bovine Reassortant Rotavirus Vaccine in Chinese Healthy Adults, Children and Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 144
- 主要终点
- Number of Participants With Serious Adverse Events
研究概览
简要总结
This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages 6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then participants in Cohort III receiving 3 doses of RotaTeq™/placebo. The primary investigator and the Ethics Review Committee will review blinded safety data and make decision based on their best clinical judgment to move study forward between cohorts. Duration for the entire study will be approximately 6-9 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Weeks 至 47 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults ages 19 to 47 years for Cohort I
- •Healthy children ages 2 to 6 years for Cohort II
- •Healthy infants ages 6 to 12 weeks for Cohort III
- •Negative pregnancy test for females in Cohort I
- •Signed Informed Consent Forms (ICFs)
排除标准
- •Participants in Cohorts I and II receiving any vaccine 14 days before or anticipated after study vaccine
- •Participants in Cohort III receiving non-concomitant live vaccines 14 days before or after study vaccine
- •Prior administration of any rotavirus vaccine
- •Elevated temperature, with axillary temperature ≥37.1 Degrees C 24 hours before study vaccine
- •Prior or active gastrointestinal illnesses, immunodeficiency
- •Any condition which may interfere with evaluation of study objectives or make participation in the study unsafe for the participant
结局指标
主要结局
Number of Participants With Serious Adverse Events
时间窗: up to 14 days post vaccination
All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.
Number of Serious Adverse Events
时间窗: 14 days post vaccination
The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.
次要结局
- Number of Infants With Fecal Vaccine Virus Shedding(Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo)