A Phase III Randomized, Modified Double-blind, Multi-centric, Comparative Study, to Evaluate Non-inferiority, Immunogenicity and Safety Cholera Vaccine Hillchol® (BBV131) to the Comparator Vaccine Shanchol™ and Hillchol® Lot Consistency
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,800
- 试验地点
- 18
- 主要终点
- Serious Adverse Events (SAEs)
研究概览
简要总结
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).
Study Population: A total of 1800 participants will be enrolled in three descending age groups(Group I- ≥18, Group II: ≥5 to <18 and Group III: ≥1 to <5). In each group,600 participants will be enrolled and will receive two doses of Hillchol® (BBV131) vaccine two weeks apart.
详细描述
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).
Study Population: A total of 1800 participants will be enrolled in three descending age groups(Group I- ≥18, Group II: ≥5 to <18 and Group III: ≥1 to <5). In each group,600 participants will be enrolled and will receive two doses of Hillchol® (BBV131) vaccine two weeks apart.
Study Objectives:
Primary Objectives:
1)To evaluate the frequency and severity of all solicited and unsolicited adverse events after administration of two doses of Hillchol® (BBV131) among all three age groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants /Legally acceptable representatives who have the ability to provide written informed consent.
- •Participants of either gender of age > 1 year.
- •Expressed interest and availability to fulfill the study requirements.
- •Willing to receive two doses of the vaccine at the specific study site.
- •Willing to be contacted on the phone to assess adverse events and for study reminders.
- •Agrees not to participate in another clinical study at any time during the study period.
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.
- •Participants with 38℃ or higher body temperature measured within 24 hours or at the time of investigational product dosing.
- •Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours before study initiation
- •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.
结局指标
主要结局
Serious Adverse Events (SAEs)
时间窗: V- :1Baseline (Day 0),V- 2: (Day 14+2),V-3: (Day 28+2),V- 4: (Day 56±7),V-5: (Day 90±7) and V- 6: (Day 180±7)
Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period.
Immediate reaction
时间窗: Within 30 mins of administration of each dose
Adverse reactions after administration of each dose
unsolicited adverse events
时间窗: 7-days
Incidence, intensity, and the causality of unsolicited adverse events during the 7-day followup period after each dose.
solicited adverse events
时间窗: 7-days
Incidence, intensity, and the causality of all solicited adverse events during the 7-day follow up period after each dose.
次要结局
未报告次要终点