Infections, RotavirusNCT01339221
Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium
An observational study of Infections, Rotavirus, run by GlaxoSmithKline at 11 sites in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 weeks to 5 years
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- Stool samples
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 11 sitesBelgium
- Study dates
- Mar 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 weeks to 5 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- Child in care.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Belgium11 sites
GSK Investigational Site
Brussels, 1020
GSK Investigational Site
Brussels, 1070
GSK Investigational Site
Deurne, 2100
GSK Investigational Site
Eeklo, 9900
GSK Investigational Site
Genk, 3600
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Kortrijk, 8500
GSK Investigational Site
Namur, 5000
GSK Investigational Site
Roeselaere, 8800
GSK Investigational Site
Sint-Truiden, 3800
GSK Investigational Site
Wilrijk, 2610
About this study
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
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.
Read the 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.
- Conditions
- Infections, Rotavirus
- Being tested
- Stool samples
- Keywords
- Observational, Rotarix™, post-marketing
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool samplesProcedure or surgery
Stool samples collected and checked for the presence of rotavirus
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Children confirmed with G1 and/or P[8] cases from the RotaBel study Receives: Procedure: Stool samples | |
| Cohort B | Children hospitalized for severe gastroenteritis in the study hospitals and tested positive for rotavirus Receives: Procedure: Stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™.
Measured: Over a three-year period
Occurrence of G1 and/or P[8] rotavirus gastroenteritis among children hospitalized with rotavirus gastroenteritis
Measured: 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
Measured: 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
Measured: 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
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.
Measured: 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
Measured: 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
Epidemiological characteristics include age, gender, centre of hospitalization, date of admission, date of discharge, duration of hospitalization, etc.
Measured: Over a three-year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, RotavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339221
- Sponsor's protocol ID
- 112560
- Status last verified
- Jan 2017
- First submitted
- 14 Apr 2011
- Last updated
- 18 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01339221
- Acronym / sponsor ID
- 112560
- Conditions
- Infections, Rotavirus
- Keywords
- Observational, Rotarix™, post-marketing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Procedure: Stool samplesChildren confirmed with G1 and/or P[8] cases from the RotaBel study |
| Cohort B | – | Procedure: Stool samplesChildren hospitalized for severe gastroenteritis in the study hospitals and tested positive for rotavirus |
Who may qualify
- Ages
- 14 weeks to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (8 listed)
- Vaccinated and unvaccinated confirmed G1 and/or P[8] rotavirus gastroenteritis cases from the RotaBel study.
- 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.
Key exclusion criteria (1 listed)
- Child in care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool samplesStool samples collected and checked for the presence of rotavirus | Procedure or surgery | Cohort A, Cohort B |
Primary outcome
Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™.
Time frame: Over a three-year period
Occurrence of G1 and/or P[8] rotavirus gastroenteritis among children hospitalized with rotavirus gastroenteritis
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Over a three-year period
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
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
Epidemiological characteristics include age, gender, centre of hospitalization, date of admission, date of discharge, duration of hospitalization, etc.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Rotavirus, run by GlaxoSmithKline at 11 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™. (time frame: Over a three-year period). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.