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

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

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

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.