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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00655187 |
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.
Condition |
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Rotavirus Severe Gastroenteritis |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Hospital-Based, Case-Control Study to Assess the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children < 5 Years of Age in KK Hospital, Singapore. |
Stool samples
Estimated Enrollment: | 960 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Weeks to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Children less than 5 years of age, hospitalised with acute GE, living in Singapore served by the hospital participating in the study (KK Hospital) (cases) and children who were born after 1 November 2005, aged at least 16 weeks and hospitalised for acute disease with non-GE causes in the same hospital, will be included in the study after matching them by date of birth (controls).
Inclusion Criteria:
Inclusion criteria for surveillance subjects
Selection criteria
For potential cases
Potential cases will be limited to those surveillance subjects:
For confirmed cases
Confirmed cases will be limited to those potential cases
For controls
All controls must satisfy the following criteria at study entry:
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:
For selection of potential cases
In addition to the exclusion criteria for surveillance subjects, potential cases will not be selected if the following criterion applies:
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:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Singapore | |
GSK Investigational Site | Recruiting |
Singapore, Singapore, 229899 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110467 |
Study First Received: | April 1, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00655187 History of Changes |
Health Authority: | Singapore: Health Sciences Authority |
Digestive System Diseases Gastrointestinal Diseases Gastroenteritis |
Digestive System Diseases Gastrointestinal Diseases Gastroenteritis |