Open, Multicentric, Post-marketing Surveillance Study to Evaluate Safety and Reactogenicity of GSK Bio's Live Attenuated Oral Human Rotavirus (HRV) Vaccine, Rotarix When Administered According to Prescribing Information, in Filipino Subjects Aged at Least 6 Weeks of Age at the Time of First Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,439
- 试验地点
- 1
- 主要终点
- Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea).
研究概览
简要总结
GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.
详细描述
The protocol was amended to reflect a change in the prescribing information. The age of the infants was changed from 6 - 14 weeks to at least 6 weeks at the time of the first vaccination. This protocol posting has been amended in order to comply with FDA AA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Weeks 至 24 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 (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •A Filipino male or female aged at least 6 weeks 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.
- •Any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract.
- •Any contraindications as stated in the Prescribing Information.
结局指标
主要结局
Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea).
时间窗: During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2).
Grade 2 or 3 symptoms assessed include fever, vomiting and diarrhea. Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C or rectal temperature above 38.5°C and below or equal to 39.5°C. Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhea was defined as at least 6 looser than normal stools per day.
次要结局
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.(During the 15-day solicited follow-up period (Day 0 to Day 14) after each vaccine dose (Dose 1 and Dose 2).)
- Number of Subjects Reporting Unsolicited Adverse Events (AE)(During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose.)
- Number of Subjects Reporting Serious Adverse Events (SAE)(Throughout the study period (Day 0 to one month post-Dose 2).)