Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized… (NCT01177657) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil
Brazil1,944 participantsStarted 2008-05
Plain-language summary
The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.
Who can participate
Age range12 Weeks
SexALL
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Inclusion Criteria:
For cases:
* A male or female child born after 6 March 2006 and at least 12 weeks of age.
* Subject admitted to the study clinics/hospitals for severe gastroenteritis during the study period.
* Onset of severe gastroenteritis ≤ 14 days prior to admission.
* Laboratory confirmed rotavirus positive stool sample at hospital admission or during the first 48 hours of hospitalization.
* Written informed consent obtained from the parent or guardian of the subject.
For controls:
* Admitted for non-gastroenteritis causes at the same clinic/hospital as the case.
* Living in the same neighbourhood as the case for at least three consecutive months without any symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/ her parents/ guardians.
* Being born within +- 2 weeks from the date of birth of the case. If the number required is not available, then the range would be extended to +- 4 weeks, and ultimately up to +- 6 weeks for hospital controls. For neighbourhood controls, the range may be extended to +- 8 weeks.
* Written informed consent obtained from the parent or guardian of the child.
Exclusion Criteria:
For cases:
* Subject has previously participated as case or control in this study.
* Onset of severe gastroenteritis \> 48 hours after admission to the hospital (nosocomial infections).
For controls:
* For hospital controls: Child who has symptoms of gastroenteritis during current hospitalization or on the day of interview of…
What they're measuring
1
Risk of Enzyme Linked Immunosorbent Assay (ELISA) confirmed rotavirus severe gastroenteritis in children fully vaccinated with Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children