A Phase II/III, Multicenter, Open-Label, Randomized Study of Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 15
- 主要终点
- Immunogenicity of rotavirus vaccine
研究概览
简要总结
This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific anti-rotavirus IgA antibodies by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of LBRV-PV by demonstrating equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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.
- •Acute disease at the time of enrollment (temporary exclusion)
- •Concurrent participation in another clinical trial at any point throughout the entire time frame for this study
- •History of congenital abdominal disorders, intussusception, or abdominal surgery.
- •Known or suspected impairment of immunological function based on medical history and physical examination.
- •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
LBRV-PV Lot A
The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot A).
干预措施: Liquid Rotavirus Vaccine (Biological)
LBRV-PV Lot B
The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot B).
干预措施: Liquid Rotavirus Vaccine (Biological)
LBRV-PV Lot C
The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot C).
干预措施: Liquid Rotavirus Vaccine (Biological)
ROTASIIL
The study participants in this arm will receive ROTASIIL, the licensed lyophilized rotavirus vaccine in India.
干预措施: Liquid Rotavirus Vaccine (Biological)
结局指标
主要结局
Immunogenicity of rotavirus vaccine
时间窗: 28 days post dose 3
Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the comparison of LBRV-PV vaccine and ROTASIIL
次要结局
- Immunogenicity Endpoints(28 days post dose 3)