Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children (NCT01177826) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children
Belgium643 participantsStarted 2008-02-23
Plain-language summary
The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.
Who can participate
Age range14 Weeks – 5 Years
SexALL
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Inclusion Criteria:
For confirmed cases:
* A male or female child born after 01 October 2006 and at least 14 weeks of age at the time of hospital admission.
* Child admitted at the study hospital for SGE during the study period.
* Onset of SGE ≤ 14 days prior to admission.
* Written informed consent obtained and signed from the parent or guardian of the child.
* Stool samples collected during the first 48 hours of hospitalisation and then tested positive for RV by PCR.
For controls:
* A male or female child born after 01 October 2006 and at least 14 weeks of age at the time of the hospital admission or visit to the hospital outpatient clinic.
* Hospitalised or visiting the hospital outpatient clinic for non-GE causes at the same hospital during the same time-period, as the probable case.
* Born within ±2 weeks from the date of birth of the case. If the list of children born within ±2 weeks is exhausted, then the range will be extended to ±4 weeks. In case a suitable control is not found even then, the range will be extended to ±6 weeks.
* Written informed consent obtained and signed from the parent or guardian of the child.
Exclusion Criteria:
For cases:
* Child has previously participated as a case or a control in this study, either in the same hospital or in another study hospital.
* Onset of SGE \>48 hours after admission to the hospital (nosocomial infections).
* Child with a condition where rotavirus vaccination would be contraindicated.
For controls:
* Child ha…
What they're measuring
1
Occurrence of PCR-confirmed rotavirus (RV) severe gastroenteritis (SGE) in children fully vaccinated with Rotarix or in unvaccinated children
Timeframe: More than 14 days after receipt of vaccine