NCT00779779已完成不适用
Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered in Sri Lankan Infants Aged at Least 6 Weeks at the Time of First Vaccination.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 522
- 试验地点
- 1
- 主要终点
- Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea
研究概览
简要总结
This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6 Weeks 至 19 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
- •A male or female at least 6 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
排除标准
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Acute disease at the time of enrolment.
- •Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
- •Any contraindication as stated in the updated and approved Prescribing Information
结局指标
主要结局
Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea
时间窗: During the 8-day solicited follow-up period
Grade 2 fever was defined as axillary temperature \> 38.0 to \<= 39.0 degrees Celsius and grade 3 fever as axillary temperature \> 39.0 degrees Celsius. Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day.
次要结局
- Number of Subjects Reporting Unsolicited Adverse Events (AEs)(During the 31-day follow-up period)
- Number of Subjects Reporting Each Type of Solicited General Symptoms(During the 8-day follow-up period)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(Throughout the study period (Day 0 to Month 3 or 4))
研究者
研究点 (1)
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