Last updated: 11/03/2018 13:03:29
Epidemiological, observational and post marketing study of Rotarix™ in children with severe gastroenteritis in Belgium
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Epidemiological, observational, post marketing study of the genetic stability of GSK Biologicals’ rotavirus vaccine (Rotarix™) in children <5 years of age diagnosed with severe gastroenteritis, in Belgium
Trial description: The main aim of this study is to investigate cases of rotavirus gastroenteritis in Belgian children with opportunity to receive Rotarix™ to monitor the potential occurrence of genetic drifts (point mutations) in the vaccine strain and the occurrence of genetic shifts (re-assortments) between vaccine and naturally circulating wild-type strains in Belgium population after the introduction of Rotarix™. The study will also detect if there is any alteration in rotavirus pathogenicity conferred by re-assortment and if the mutated vaccine strain is still efficacious in preventing rotavirus gastroenteritis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™.
Timeframe: Over a three-year period
Occurrence of G1 and/or P[8] rotavirus gastroenteritis among children hospitalized with rotavirus gastroenteritis
Timeframe: Over a three-year period
Occurrence of vaccine-derived G1 and/or P[8] encoding gene segments among children hospitalized with rotavirus gastroenteritis due to G1 and/or P[8] strains
Timeframe: Over a three-year period
Occurrence of mutated vaccine strains and re-assortments among hospitalized children with vaccine-derived G1 and/or P[8] encoding gene segments
Timeframe: Over a three-year period
Clinical characteristics of hospitalized children with vaccine-derived G1 and/or P[8] encoding gene segments, and with vaccine-derived re-assortant strains and vaccine-derived mutated strains
Timeframe: Over a three-year period
Occurrence of co-infections due to other common viral intestinal pathogens (norovirus, astrovirus, adenovirus) among hospitalized children with rotavirus gastroenteritis
Timeframe: Over a three-year period
Epidemiological characteristics of hospitalized children with vaccine-derived G1 and/or P(8) encoding gene segments, and with vaccine-derived re-assortant strains and vaccine-derived mutated strains
Timeframe: Over a three-year period
Secondary outcomes:
Not applicable
Interventions:
Procedure/surgery: Stool samples
Enrollment:
72
Observational study model:
Case-Only
Primary completion date:
2012-20-06
Time perspective:
Other
Clinical publications:
Not applicable
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
March 2011 to June 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
14 weeks - 5 years
Accepts healthy volunteers
No
- Phase I:
- Vaccinated and unvaccinated confirmed G1 and/or P[8] rotavirus gastroenteritis cases from the RotaBel study.
- Child in care.
Inclusion and exclusion criteria
Inclusion criteria:
- Vaccinated and unvaccinated confirmed G1 and/or P[8] rotavirus gastroenteritis cases from the RotaBel study. Phase II:
- A male or a female, born after 1 October 2006 and aged between 14 weeks and < 5 years at the time of hospital admission.
- Child admitted at the study hospital for severe gastroenteritis during the study period.
- Onset of severe gastroenteritis ≤14 days prior to admission.
- Child whose stool sample was tested positive for rotavirus by a hospital routine test.
- Written informed consent obtained from the parent or guardian of the child.
Phase I:
Exclusion criteria:
Child in care.
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
2012-20-06
Actual study completion date
2012-20-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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