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

Launched by GLAXOSMITHKLINE · Aug 6, 2010

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.