NCT00655187已完成不适用
Case-control Study to Evaluate the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children < 5 Years of Age in KK Hospital, Singapore
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,270
- 试验地点
- 1
- 主要终点
- To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis (RV SGE) among children born after 1 November 2005 and aged at least 16 weeks.
研究概览
简要总结
This study aims to evaluate the effectiveness of Rotarix™ vaccine in the general population in Singapore by monitoring the overall reduction in RV SGE and also by assessing the direct protection offered by the vaccine in hospitalised infants through a case-control study.
详细描述
This Protocol Posting has been updated following an amendment of the Protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for surveillance subjects
- •A male or female child aged < 60 months at the time of admission (a child becomes ineligible on the day of its fifth birthday).
- •Subject admitted with acute GE as an inpatient to the study site during the study period.
- •Written informed consent obtained from the parent or guardian of the subject. Selection criteria for cases
- •Cases will be limited to those surveillance subjects:
- •who are born after 1 November 2005 (date of availability of Rotarix™ vaccination in Singapore),
- •who are aged at least 16 weeks at the time of hospital admission.
- •whose stool samples are tested positive for RV. Selection criteria for controls
- •All controls must satisfy the following criteria at study entry:
- •Admitted for acute disease with non-GE causes in the same hospital as the case , with the closest admission date to the cases.
- •Aged at least 16 weeks at the time of hospital admission.
- •Born within a range of ± 2 weeks from the date of birth of cases. In case there is no suitable match, then the range would be extended to ± 4 weeks.
- •Written informed consent obtained from the subject's parents/guardians.
排除标准
- •For enrolment of surveillance subjects
- •The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- •The diagnoses at admission to the study site do not include acute GE.
- •Children for whom stool samples are not available up to 48 hours after admission.
- •The onset of GE is after 48 hours of admission to the hospital (i.e. nosocomial GE).
- •Children with a history of chronic and genetic diseases. For selection of cases
- •In addition to the exclusion criteria for surveillance subjects, cases will not be selected if the following criterion applies:
- •Subjects who had a previous episode of acute GE less than a week back i.e. recurrent GE episode.
- •Subjects who have been already enrolled in the study.
- •Subjects whose vaccination history could not be ascertained. For selection of controls
- •The following criteria should be checked at the time of study entry. If any apply, the controls must not be included in the study:
- •Child who has symptoms of GE on the day of interview of his/her parent or guardian or had an episode of GE within 14 days prior to the day of interview.
- •Child who has been already enrolled in the study as case or control.
- •The onset of GE occurs after admission at the hospital.
- •Child whose vaccination history could not be ascertained.
结局指标
主要结局
To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis (RV SGE) among children born after 1 November 2005 and aged at least 16 weeks.
时间窗: At least one year
To estimate the proportion of acute RV GE hospitalisations in children < 5 years of age.
时间窗: At least one year
次要结局
- To determine the distributions of acute RV GE associated hospital admissions according to subject's age, gender and by month of year.(At least one year)
- To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing hospitalisation for acute RV GE among children born after 1 November 2005 and aged at least 16 weeks.(At least one year)
- To estimate the prevalence of RV genotypes in acute RV GE associated hospital admission.(At least one year)
- To review the trend of acute RV GE and acute GE admissions over the entire study period.(At least one year)
研究者
研究点 (1)
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