Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7,500
- 试验地点
- 6
- 主要终点
- occurrence of Severe Rotavirus Gastroenteritis
研究概览
简要总结
This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.
详细描述
The hypothesis is that a three dose series of BRV-PV administered orally to healthy Indian infants, with the initial dose given at 6-8 weeks of age and followed by vaccinations at monthly intervals, will significantly reduce the incidence of severe rotavirus gastroenteritis (SRVGE). Duration of follow-up is until aged 2 years of each enrolled child. The study is powered to detect vaccine efficacy significantly greater than 10% (95% confidence interval lower bound > 10%) if the true vaccine efficacy is 50% or higher.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants as established by medical history and clinical examination before entering the study.
- •Age: 6-8 weeks at the time of enrollment.
- •Parental ability and willingness to provide informed consent.
- •Parent who intends to remain in the area with the child during the study period.
排除标准
- •Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion)
- •Presence of fever on the day of enrollment (temporary exclusion).
- •Acute disease at the time of enrollment (temporary exclusion)
- •Concurrent participation in another clinical trial throughout the entire timeframe for this study.
- •Presence of significant malnutrition (weight-for-height z-score <-3SD median) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the subject's health or is likely to result in nonconformance to the protocol. History of congenital abdominal disorders, intussusception or abdominal surgery
- •Known or suspected impairment of immunological function based on medical history and physical examination.
- •Household contact with an immunosuppressed individual or pregnant woman.
- •Prior receipt of rotavirus vaccine.
- •A known sensitivity or allergy to any components of the study vaccine.
- •Major congenital or genetic defect.
- •History of persistent diarrhea (defined as diarrhea more than 14 days).
- •Participant's parents not able, available or willing to accept active weekly follow-up by the study staff.
- •Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
- •History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
- •History of any neurologic disorders or seizures.
- •Any medical condition in the parents/infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent.
研究组 & 干预措施
Vaccine Arm
3 doses, 4 weeks apart, of Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent
干预措施: Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV) (Biological)
Placebo group
3 doses, 4 weeks apart, of Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents
干预措施: Placebo (Other)
结局指标
主要结局
occurrence of Severe Rotavirus Gastroenteritis
时间窗: Up to 2 years of age of participants
Laboratory confirmed cases of severe rotavirus gastroenteritis occurring in infants receiving the complete vaccination regimen occurring from 14 days after the third vaccine dose until 122 cases are accrued, or until all participating infants reach two years of age (per protocol analysis).
次要结局
- Safety(Until completion of 2 years age of participant)