NCT00383903已完成2 期
A Phase II, Randomized, Double-blind, Placebo-controlled Study of Safety, Reactogenicity and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at 10E6.5 CCID50 Viral Concentration in Healthy Infants (Approximately 5-10 Weeks Old) in the Republic of South Africa
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 472
- 试验地点
- 6
- 主要终点
- Seroconversion after HRV vaccination
研究概览
简要总结
The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.
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
- Double
入排标准
- 年龄范围
- 5 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants born after a normal gestation period (>=36 weeks), between 5 and 10 weeks of age at Dose 1 with confirmed negative HIV status of the subject's mother.
- •Written informed consent was obtained from the parent/guardian of the subject before study entry.
排除标准
- •History of allergic disease/polio disease,
- •Confirmed or suspected immunosuppressive or immunodeficient condition,
- •Clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator,
- •Received treatment prohibited by the protocol.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
结局指标
主要结局
Seroconversion after HRV vaccination
次要结局
- shedding, serum anti-rota IgA antibody concentrations, anti-polio 1, 2 and 3 seroprotection rates, reactogenicity, safety
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy InfantsHepatitis BNCT00429481GlaxoSmithKline2,464
已完成
2 期
To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPVRotavirus InfectionsNCT00346892GlaxoSmithKline450
已完成
3 期
To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)Infections, RotavirusNCT00345956GlaxoSmithKline375
已完成
2 期
A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARSRespiratory Tract InfectionNCT04071158Pfizer713
已完成
2 期
A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in BangladeshInfections, RotavirusNCT00139334GlaxoSmithKline300