A Phase III, Multicenter, Open Label, Randomized Study of Bovine Rotavirus Pentavalent Vaccine (BRV-PV) to Evaluate Lot-To-Lot Consistency and to Investigate Potential Interference With Routine UIP Vaccinations in Healthy Infants in India.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 19
- 主要终点
- Rotavirus vaccine lots Immunogenicity
研究概览
简要总结
This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).
详细描述
The study is designed to evaluate lot-to-lot consistency in the manufacturing of Rotavirus vaccine by testing the vaccine in infants in order to demonstrate equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots. The study will also examine the potential interference of vaccine with UIP vaccines that will be administered concurrently by assessing non-inferiority in the immune responses to those vaccines when administered with / without the study vaccine.
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
- 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 written informed consent.
- •Parent who intends to remain in the area with the child during the study period.
- •Receipt of birth dose of Hepatitis B vaccine and OPV.
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 at any point throughout the entire timeframe for this study.
- •Presence of significant malnutrition or any systemic disorder 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 or intent to receive rotavirus and / or diphtheria, tetanus, pertussis, Haemophilus Influenzae type b, Hepatitis B vaccine (other than birth dose) or inactivated polio vaccine (IPV) during the study period and outside of the study. OPV dose received during national / subnational immunization days will be allowed.
- •A known sensitivity or allergy to any components of the study vaccine.
- •Clinically detectable congenital or genetic defect.
- •History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
- •Receipt of 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 written informed consent.
研究组 & 干预措施
Group 1 - BRV-PV Lot A
BRV-PV Lot A + DPT- HepB-Hib + OPV
干预措施: BRV-PV Lot A + DPT-HepB-Hib + OPV (Biological)
Group 2 - BRV-PV Lot B
BRV-PV Lot B+ DPT- HepB-Hib + OPV
干预措施: BRV-PV Lot B + DPT-HepB-Hib + OPV (Biological)
Group 3 - BRV-PV Lot C
BRV-PV Lot C + DPT- HepB-Hib + OPV
干预措施: BRV-PV Lot C + DPT-HepB-Hib + OPV (Biological)
Group 4 - ROTARIX
ROTARIX + DPT-HepB-Hib + OPV
干预措施: ROTARIX + DPT-HepB-Hib + OPV (Biological)
结局指标
主要结局
Rotavirus vaccine lots Immunogenicity
时间窗: Four weeks after the third dose of vaccination
Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the BRV-PV to demonstrate equivalence in lot consistency among three lots.
Immunogenicity of UIP vaccines
时间窗: Four weeks after the third dose of vaccination
次要结局
- Rotavirus Immunogenicity:(Four weeks after the third dose of vaccination)
- Immediate adverse events and Solicited post -vaccination reactogenicity(AEs within 30 minutes post-vaccination and post vacc reactogenicity during 7 days after each vaccination)