A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10,708
- 试验地点
- 4
- 主要终点
- Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
研究概览
简要总结
The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.
详细描述
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age in Hongkong and Taiwan or 11-17 weeks of age in Singapore, according to a 0, 1 to 2-month schedule. Routine vaccinations are given concomitantly with the study vaccines at 2 or 3 and 4 months of age according to each local country regulation. Whenever OPV is used, a minimum 2-week interval should be observed between HRV vaccine and OPV doses.
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)
入排标准
- 年龄范围
- 6 Weeks 至 17 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants 6-12 or 11-17 weeks of age at the time of dose 1 whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- •Child is unlikely to remain in the study area during study.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- •Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
- •First or second degree of consanguinity of parents.
结局指标
主要结局
Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
次要结局
- Severe RV GE by wild-type G1, non-G1, each non-G1 and severe GE from 2 weeks after Dose 1 and 2 until 2-year old. SAEs. Mortality. Definite IS until 2-years old. Serum anti-RV IgA at Visits 1 and 3 (100 subjects/country).