Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children

Study Overview
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Brief Summary
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The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.

Official Title
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Case-control Study to Evaluate the Vaccine Effectiveness of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix™) Against Community-acquired Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children Born After 1 October 2006, in Belgium

Conditions
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Infections, Rotavirus, Rotavirus Vaccines

Intervention / Treatment
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* Procedure: Sample collection


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 14 Weeks
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Cases | Procedure: Sample collection<br>* Stool sample<br>|
| Group 2<br>Controls | Procedure: Sample collection<br>* Stool sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospitalized, Rotavirus, Children, effectiveness, Gastroenteritis