Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01339221
First received: April 14, 2011
Last updated: October 11, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Rotavirus Gastroenteritis |
Procedure: Stool samples |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Gastroenteritis
Drug Information available for:
Rotarix
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™. [ Time Frame: Over a three-year period ] [ Designated as safety issue: No ]
- Occurrence of G1 and/or P[8] rotavirus gastroenteritis among children hospitalized with rotavirus gastroenteritis [ Time Frame: Over a three-year period ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Over a three-year period ] [ Designated as safety issue: No ]
- Occurrence of mutated vaccine strains and re-assortments among hospitalized children with vaccine-derived G1 and/or P[8] encoding gene segments [ Time Frame: Over a three-year period ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Over a three-year period ] [ Designated as safety issue: No ]Clinical characteristics include symptoms of current gastroenteritis (GE) episode, severity of GE episode by Vesikari score, date of onset of GE episode, diagnosis at admission, diagnosis at discharge, treatment, medical history and co-infections.
- Occurrence of co-infections due to other common viral intestinal pathogens (norovirus, astrovirus, adenovirus) among hospitalized children with rotavirus gastroenteritis [ Time Frame: Over a three-year period ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Over a three-year period ] [ Designated as safety issue: No ]Epidemiological characteristics include age, gender, centre of hospitalization, date of admission, date of discharge, duration of hospitalization, etc.
Biospecimen Retention: Samples Without DNA
Stool samples
| Enrollment: | 26 |
| Study Start Date: | May 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Cohort A
Children confirmed with G1 and/or P[8] cases from the RotaBel study
|
Procedure: Stool samples
Stool samples collected and checked for the presence of rotavirus
|
|
Cohort B
Children hospitalized for severe gastroenteritis in the study hospitals and tested positive for rotavirus
|
Procedure: Stool samples
Stool samples collected and checked for the presence of rotavirus
|
Detailed Description:
This study is conducted in two phases: Phase I and Phase II. Phase I will be retrospective and consist of re-using the data collected in RotaBel (EPI-ROTA-111426) study. Phase II will be prospective and consist of maintaining the active surveillance system to identify rotavirus cases in several hospitals in Belgium.
Eligibility| Ages Eligible for Study: | 14 Weeks to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Children confirmed with G1 and/or P[8] cases from the RotaBel study, children between 14 weeks and <5 years of age, hospitalized for severe gastroenteritis in the study hospitals and who are tested positive for rotavirus
Criteria
Inclusion Criteria:
Phase I:
• 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.
Exclusion Criteria:
• Child in care.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339221
Locations
| Belgium | |
| GSK Investigational Site | |
| Brussels, Belgium, 1020 | |
| GSK Investigational Site | |
| Deurne, Belgium, 2100 | |
| GSK Investigational Site | |
| Eeklo, Belgium, 9900 | |
| GSK Investigational Site | |
| Genk, Belgium, 3600 | |
| GSK Investigational Site | |
| Gent, Belgium, 9000 | |
| GSK Investigational Site | |
| Kortrijk, Belgium, 8500 | |
| GSK Investigational Site | |
| Namur, Belgium, 5000 | |
| GSK Investigational Site | |
| Roeselaere, Belgium, 8800 | |
| GSK Investigational Site | |
| Sint-Truiden, Belgium, 3800 | |
| GSK Investigational Site | |
| Wilrijk, Belgium, 2610 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01339221 History of Changes |
| Other Study ID Numbers: | 112560 |
| Study First Received: | April 14, 2011 |
| Last Updated: | October 11, 2012 |
| Health Authority: | Belgium: Agence Fédérale des Médicaments et des Produits de la Santé |
Keywords provided by GlaxoSmithKline:
|
Observational Rotarix™ post-marketing |
Additional relevant MeSH terms:
|
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013