Last updated: 12/31/2019 05:10:04
Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: 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
Trial description: The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of PCR-confirmed rotavirus (RV) severe gastroenteritis (SGE) in children fully vaccinated with Rotarix or in unvaccinated children
Timeframe: More than 14 days after receipt of vaccine
Secondary outcomes:
Occurrence of PCR-confirmed RV SGE in children who received one or two doses of Rotarix or in unvaccinated children
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Average time frame: 1 year from the date of subject enrolment
Interventions:
Procedure/surgery: Sample collection
Enrollment:
643
Observational study model:
Case-Control
Primary completion date:
2010-11-06
Time perspective:
Prospective
Clinical publications:
Braeckman T et al. (2012) Effectiveness of rotavirus vaccination in prevention of hospital admissions for rotavirus gastroenteritis among young children in Belgium: case-control study. BMJ. 2012 Aug 8;345:e4752. doi: 10.1136/bmj.e4752.
Braeckman T et al. Vaccine effectiveness against Community-Acquired severe Rotavirus gastroenteritis among infants, in Belgium: A hospital-based, prospective, case control study. Abstract presented at the 11th International Symposium on Double-Stranded RNA Viruses, San Juan, Puerto Rico, 27 Nov - 01 Dec 2012.
Matthijnssens J et al. Genotype-specific vaccine effectiveness against rotavirus gastroenteritis hospitalisation among young children in Belgium. Abstract presented at the 11th International Symposium on Double-Stranded RNA Viruses, San Juan, Puerto Rico, 27 Nov - 01 Dec 2012.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
February 2008 to June 2010
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
14 weeks - 5 years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
For confirmed cases:
Exclusion criteria:
- 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.
For cases:
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2010-11-06
Actual study completion date
2010-11-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website