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

Completed

• Conditions: Rotavirus Vaccines; Infections, Rotavirus
• Interventions: Procedure: Sample collection

• Registration Number: NCT01177826
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-23
• Primary Completion: 2010-06-11
• Study Completion: 2010-06-11
• Study First Submitted: 2010-08-06
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-09
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-31
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 643

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Sample collection	Controls
Group 1	Sample collection	Cases

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 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

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇪 Wilrijk, Belgium