A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the non-inferiority of immunogenicity and safety of single strain oral cholera vaccine Hillchol® (BBV131) to the comparator vaccine Shanchol™ along with lot-to-lot consistency of Hillchol® (BBV131).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,800
- 试验地点
- 10
- 主要终点
- To evaluate the frequency and
研究概览
简要总结
In this study, a total sample size of 1800 participants will be enrolled in three age groups and administered with Hillchol® (BBV131).
Group-I (Age: ≥18): In this group, a total of 600 participants aged ≥18 will be enrolled and administered two doses of Hillchol® (BBV131) on day 0 and 14.
Group-II (Age: ≥5 to <18): In this group, a total of 600 participants aged ≥5 to <18 will be enrolled and administered two doses of Hillchol® (BBV131) on day 0 and 14.
Group-III (Age: ≥1 to <5): In this group, a total of 600 participants aged ≥1 to <5 will be enrolled and administered two doses of Hillchol® (BBV131) on day 0 and 14.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- Participants /Legally acceptable representatives who have the ability to provide written informed consent.
- Participants of either gender of age .
- Expressed interest and availability to fulfill the study requirements.
- Willing to receive two doses of the vaccine at the specific study site.
排除标准
- Any history of anaphylaxis in relation to vaccination.
- Participants with Immune function disorders including immunodeficiency diseases, or taking immunosuppressive/cytotoxic agents.
- An individual is thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator.
- Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours before study initiation 6.
- Diarrhea or administration of anti-diarrheal drugs or antibiotics to treat diarrhea within 1 week before study initiation.
- Other vaccination within 4 weeks before study initiation.
- Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months before study initiation.
- Participation in another clinical trial.
- History of cholera vaccinations or history of cholera diarrhea.
- Pregnancy, lactation or willingness/intention to become pregnant during the study.
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- History of any psychiatric condition likely to affect participation in the study.
- Suspected or known current alcohol abuse is defined by an alcohol intake of greater than 42 units every week.
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the study or would render the subject unable to comply with the protocol.
结局指标
主要结局
To evaluate the frequency and
时间窗: Day 0 and 14
severity of all solicited and
时间窗: Day 0 and 14
unsolicited adverse events after administration of two doses of
时间窗: Day 0 and 14
Hillchol® (BBV131) among all three age groups.
时间窗: Day 0 and 14
次要结局
- not applicable(not applicable)
研究者
研究点 (10)
标识符
- CTRI 编号
- CTRI/2023/01/049320
- 其他研究编号
- BBIL/BBV-Hillchol®(BBV131)/2021Addendum01dated 12.01.2023
日期
- 最近更新
- (2年前)
监管与共享
- 个体参与者数据共享计划
- 否
Will individual participant data (IPD) be shared publicly (including data dictionaries)? Response - NO