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

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Rotavirus Vaccines

Infections, Rotavirus

Treatments

Procedure: Sample collection

Study type

Observational

Funder types

Industry

Identifiers

NCT01177826

111426

Details and patient eligibility

About

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

Enrollment

643 patients

Sex

All

Ages

14 weeks to 5 years old

Volunteers

No Healthy Volunteers

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.