To Assess Long-term Efficacy & Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in the Primary Vaccination Study (102247).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,613
- 试验地点
- 15
- 主要终点
- Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)
研究概览
简要总结
To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247). The Rotarix vaccine was administered in the primary vaccination study. There was no vaccine/intervention in this long-term efficacy study.
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
- 32 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female who has completed the second year efficacy follow-up of the primary vaccination study in Finland.
- •Written informed consent obtained from the parent or guardian of the subject.
排除标准
- 未提供
研究组 & 干预措施
Rotarix Group
Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
干预措施: Rotarix (primary vaccination study) (Biological)
Placebo Group
Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
干预措施: Placebo (primary vaccination study) (Biological)
结局指标
主要结局
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)
时间窗: During the study period for the long-term follow-up (i.e. 6 months)
Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.
次要结局
- Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)(During the study period for the long-term follow-up (i.e. 6 months))
- Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype(During the study period for the long-term follow-up (i.e. 6 months))
- Number of Subjects Reporting Serious Adverse Events (SAEs)(During the study period for the long-term follow-up (i.e. 6 months))
- Number of Subjects With Severe Gastroenteritis (GE)(During the study period for the long-term follow-up (i.e. 6 months))
- Number of Subjects Reporting Intussusception (IS)(During the period starting from the end of the second follow-up up to the start of the study (up to 6 months))
- Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype(During the study period for the long-term follow-up (i.e. 6 months))
- Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype(During the study period for the long-term follow-up (i.e. 6 months))
- Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype(During the study period for the long-term follow-up (i.e. 6 months))