A Phase IIIb, Partially Blind, Randomized, Placebo-controlled Study to Asses the Effect on Immunogenicity of Administration of Vaccine Without Buffering Agent and to Assess Heat Stability in Terms of Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Following a 0, 2 Month Schedule, in Healthy Infants Previously Uninfected With Human Rotavirus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 3
- 主要终点
- Percentage of subjects with vaccine take
研究概览
简要总结
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age. GSK Biologicals has developed a vaccine against human rotavirus gastroenteritis. In this study, the immunogenicity, reactogenicity and safety of the HRV vaccine will be evaluated when stored or reconstituted in circumstances different from the recommendations: i.e. when not reconstituted with a buffer or when stored for 7 days at 37°C before reconstitution. In addition, the effect of feeding will be explored for HRV vaccine reconstituted without buffer.
详细描述
Assess the effect on immunogenicity of administration of vaccine without buffering agent & assess heat stability in terms of immunogenicity, reactogenicity & safety of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine following a 0,2 m schedule, in healthy infants previously uninfected with human rotavirus
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
- Single
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of subjects with vaccine take
时间窗: At 2 months post-Dose 2
次要结局
- Percentage of subjects who seroconverted (percentage of subjects with concentrations ≥ 20 U/mL in subjects who were negative for rotavirus (RV) before vaccination)(At 2 months post-Dose 2)
- Evaluation of the serum anti-RV IgA (immunoglobulin A) antibody concentrations expressed as Geometric Mean Concentrations (GMC)(At 2 months post-Dose 2)
- Rotavirus antigen shedding in planned stool samples(At Day 0, Day 7 and Day 15 post each study vaccine dose)
- Presence of RV in gastroenteritis (GE) episode stools collected(From Dose 1 of HRV vaccine/placebo up to 2 months post-Dose 2)
- For each type of solicited symptoms, occurrence of the symptom(Within the 15-day (Day 0-14) solicited follow-up period after each study vaccine dose)
- Occurrence of any Grade 2 or Grade 3 fever, vomiting or diarrhea(Within the 15-day (Day 0-14) solicited follow-up period after each study vaccine dose)
- Occurrence of unsolicited adverse events (AEs) according to Medical Dictionary for Regulatory Activities (MedDRA) classification(Within 31 days (Day 0-30) after each study vaccine dose)
- Occurrence of serious adverse events (SAEs) according to MedDRA classification(Throughout the study period (Day 0 to Month 4))