Effectiveness of Human Rotavirus Vaccine, Rotarix™ Against Rotavirus Severe Gastroenteritis (RV S… (NCT00655187) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Human Rotavirus Vaccine, Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants
Singapore1,270 participantsStarted 2008-04
Plain-language summary
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.
Who can participate
Age range5 Years
SexALL
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Inclusion Criteria:
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.
Exclusion Criteria:
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…
What they're measuring
1
To estimate the proportion of acute RV GE hospitalisations in children < 5 years of age.
Timeframe: At least one year
2
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.