Infections, Rotavirus, Rotavirus Vaccines
Conditions
Keywords
Hospitalized, Rotavirus, Children, effectiveness, Gastroenteritis
Brief summary
The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.
Interventions
PROCEDURESample collection
Stool sample
Sponsors
GlaxoSmithKline
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Weeks to 5 Years
Healthy volunteers
No
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of PCR-confirmed rotavirus (RV) severe gastroenteritis (SGE) in children fully vaccinated with Rotarix or in unvaccinated children | More than 14 days after receipt of vaccine |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of PCR-confirmed RV SGE in children who received at least one dose of Rotarix or Rotateq in unvaccinated children | More than 14 days after receipt of vaccine |
| Occurrence of SGE due to RV among children born after 01 October 2006, at least 14 weeks of age and admitted to hospital | Average time frame: 1 year from the date of subject enrolment |
| Occurrence of PCR-confirmed RV SGE in children who received one or two doses of Rotarix or in unvaccinated children | More than 14 days after receipt of vaccine |
| Occurrence of PCR-confirmed RV SGE by age and month of year, among children born after 01 October 2006, at least 14 weeks of age and admitted to the hospital | Average time frame: 1 year from the date of subject enrolment |
| Occurrence of RV serotypes among hospitalized PCR-confirmed RV SGE children born after 01 October 2006 and at least 14 weeks of age | Average time frame: 1 year from the date of subject enrolment |
| Occurrence of co-infections with other organisms among children born after 1 October 2006, at least 14 weeks of age and hospitalized with PCR-confirmed RV SGE | Average time frame: 1 year from the date of subject enrolment |
Countries
Belgium
Outcome results
None listed