Status:
COMPLETED
Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Rotavirus Vaccines
Eligibility:
All Genders
14-5 years
Brief Summary
The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.
Eligibility Criteria
Inclusion
- 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
- 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 has participated in the past as a case or control in this study, either in the same hospital or in another study hospital.
- Child who has symptoms of GE/ SGE during current hospital stay/ visit to the hospital outpatient clinic or on the day of interview of his/her parent or guardian.
- Child with a condition where rotavirus vaccination would be contraindicated.
Key Trial Info
Start Date :
February 23 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 11 2010
Estimated Enrollment :
643 Patients enrolled
Trial Details
Trial ID
NCT01177826
Start Date
February 23 2008
End Date
June 11 2010
Last Update
January 3 2020
Active Locations (29)
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1
GSK Investigational Site
Antwerp, Belgium, 2020
2
GSK Investigational Site
Brussels, Belgium, 1020
3
GSK Investigational Site
Brussels, Belgium, 1050
4
GSK Investigational Site
Brussels, Belgium, 1070