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
- 入组人数
- 1,800
- 试验地点
- 16
- 主要终点
- Primary Outcome
研究概览
简要总结
A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the noninferiority 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 3(1350):1(450) ratio. In each group 600 participants will be enrolled and among 600 participants 450 participants will receive any lot of Hillchol® (BBV131) and 150 participants will receive Shanchol™.
DSMB and report:After completion of 7 days post 1st dose for 40 participants (Hillchol (BBV131):10-Lot-I,10-Lot-II,10-Lot-III and 10-shanchol) in the Group I, safety data of these participants will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 560 participants in the group I and starting recruitment of participants for group II.
After completion of 7 days post 1st dose for 40 participants (Hillchol (BBV131):10-Lot-I,10-Lot-II,10-Lot-III and 10-shanchol) in the Group II, safety data of these participants will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 560 participants in the group II and starting recruitment of participants for group III.
After completion of 7 days post 1st dose for 40 participants (Hillchol (BBV131): 10-Lot-I, 10-Lot-II, 10-Lot-III and 10-shanchol) in the Group III, safety data of these subjects will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 560 participants in the group III.
A Final report will be generated, based on the safety and immunogenicity of the oral cholera vaccine (Hillchol®) will be notified to the Data safety monitoring board and Central Drugs Standard Control Organization (CDSCO), India.
详细描述
A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the noninferiority 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 3(1350):1(450) ratio. In each group 600 participants will be enrolled and among 600 participants 450 participants will receive any lot of Hillchol® (BBV131) and 150 participants will receive Shanchol™.
Study objectives:
Primary Objectives:
- To demonstrate non-inferiority of immunogenicity Hillchol®(BBV131) to that of Shanchol by comparing the seroconversion rate (defined as '4 fold rise in vibriocidal antibody titer compared to baseline') upon administration of 2 doses of Hillchol®(BBV131) or Shanchol, across all age groups. Secondary
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blind Study
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 ability to provide written informed consent.
- •Participants of either gender of age > 1 year.
- •Expressed interest and availability to fulfil the study requirements.
- •Willing to receive two dosesof 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.
- •Participant with Immune function disorders including immunodeficiency diseases, or taking immunosuppressive/cytotoxic agents.
- •An individual 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 prior to study initiation
- •Diarrhea or administration of anti-diarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation.
- •Other vaccination within 4week prior to study initiation.
- •Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to 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 as 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
Primary Outcome
时间窗: 14 days after 2 doses of test or comparator vaccine
The proportion of participants achieving seroconversion against Ogawa serotype, 14 days after 2 doses of test or comparator vaccine. 2)The proportion of participants achieving seroconversion against Inaba serotype, 14 days after 2 doses of test or comparator vaccine.
次要结局
- Secondary Outcome(during the 14-day follow-up period after each dose.)
- Secondary outcome(14 days after 2 doses for each consecutive batch of Hillchol®(BBV131)