Infections, RotavirusNCT01177826
Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children
An observational study of Infections, Rotavirus and Rotavirus Vaccines, run by GlaxoSmithKline at 29 sites in Belgium.
Trial summary
The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium. Read more about this study
- Who is it for?
- Ages 14 weeks to 5 years
- Conditions the study is for
- Infections, Rotavirus, Rotavirus Vaccines
- What is being tested?
- Sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 643 participants
- Where
- 29 sitesBelgium
- Study dates
- 23 Feb 2008to 11 Jun 2010
- 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: The confirmed cases are children born after 01 October 2006, at least 14 weeks of age, hospitalized for SGE during the designated study period and whose stool samples have been tested positive for RV by polymerase chain reaction (PCR). The controls are those children hospitalised or visiting the hospital outpatient clinic for non-GE causes at the study hospitals during the same time-period as the case and will be included after matching by age.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Belgium29 sites
GSK Investigational Site
Antwerp, 2020
GSK Investigational Site
Brussels, 1020
GSK Investigational Site
Brussels, 1050
GSK Investigational Site
Brussels, 1070
GSK Investigational Site
Brussels, 1180
GSK Investigational Site
Chimay, 6460
GSK Investigational Site
Deinze, 9800
GSK Investigational Site
Deurne, 2100
GSK Investigational Site
Edegem, 2650
GSK Investigational Site
Eeklo, 9900
GSK Investigational Site
Genk, 3600
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Gosselies, 6041
GSK Investigational Site
Hasselt, 3500
GSK Investigational Site
Heusden, 3550
GSK Investigational Site
Hornu, 7301
GSK Investigational Site
Ieper, 8900
GSK Investigational Site
Kortrijk, 8500
GSK Investigational Site
Merksem, 2170
GSK Investigational Site
Mons, 7000
GSK Investigational Site
Namur, 5000
GSK Investigational Site
Nivelles, 1400
GSK Investigational Site
Ostend, 8400
GSK Investigational Site
Ottignies, 1340
GSK Investigational Site
Roeselaere, 8800
GSK Investigational Site
Sint-Niklaas, 9100
GSK Investigational Site
Sint-Truiden, 3800
GSK Investigational Site
Tongeren, 3700
GSK Investigational Site
Wilrijk, 2610
About this study
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
The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.
- Conditions
- Infections, Rotavirus, Rotavirus Vaccines
- Being tested
- Sample collection
- Keywords
- Hospitalized, Rotavirus, Children, effectiveness, Gastroenteritis
- Medical subject headings
- Rotavirus Infections, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionProcedure or surgery
Stool sample
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Cases Receives: Procedure: Sample collection | |
| Group 2 | Controls Receives: Procedure: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of PCR-confirmed rotavirus (RV) severe gastroenteritis (SGE) in children fully vaccinated with Rotarix or in unvaccinated children
Measured: More than 14 days after receipt of vaccine
Secondary outcomes (6)
Occurrence of PCR-confirmed RV SGE in children who received one or two doses of Rotarix or in unvaccinated children
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Average time frame: 1 year from the date of subject enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study start23 Feb 2008
- Primary completion11 Jun 2010
- Study completion11 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 643 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
- NCT01177826
- Sponsor's protocol ID
- 111426
- Status last verified
- Dec 2019
- First submitted
- 6 Aug 2010
- Last updated
- 3 Jan 2020
- Results posted
- No
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Publications
Braeckman T, Van Herck K, Meyer N, Pircon JY, Soriano-Gabarro M, Heylen E, Zeller M, Azou M, Capiau H, De Koster J, Maernoudt AS, Raes M, Verdonck L, Verghote M, Vergison A, Matthijnssens J, Van Ranst M, Van Damme P; RotaBel Study Group. 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.
PubMed 22875947Braeckman 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01177826
- Acronym / sponsor ID
- 111426
- Conditions
- Infections, Rotavirus, Rotavirus Vaccines
- Keywords
- Hospitalized, Rotavirus, Children, effectiveness, Gastroenteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2008 (actual)
- Primary completion
- 11 Jun 2010 (actual)
- Study completion
- 11 Jun 2010 (actual)
- First posted
- 9 Aug 2010 (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 purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Sample collectionCases |
| Group 2 | – | Procedure: Sample collectionControls |
Who may qualify
- Ages
- 14 weeks to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The confirmed cases are children born after 01 October 2006, at least 14 weeks of age, hospitalized for SGE during the designated study period and whose stool samples have been tested positive for RV by polymerase chain reaction (PCR). The controls are those children hospitalised or visiting the hospital outpatient clinic for non-GE causes at the study hospitals during the same time-period as the case and will be included after matching by age.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- 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.
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 |
|---|---|---|
| Sample collectionStool sample | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Occurrence of PCR-confirmed rotavirus (RV) severe gastroenteritis (SGE) in children fully vaccinated with Rotarix or in unvaccinated children
Time frame: More than 14 days after receipt of vaccine
6 secondary outcomes
Occurrence of PCR-confirmed RV SGE in children who received one or two doses of Rotarix or in unvaccinated children
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Average time frame: 1 year from the date of subject enrolment
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 3 Jan 2020.
- Background: PubMed 22875947Braeckman T, Van Herck K, Meyer N, Pircon JY, Soriano-Gabarro M, Heylen E, Zeller M, Azou M, Capiau H, De Koster J, Maernoudt AS, Raes M, Verdonck L, Verghote M, Vergison A, Matthijnssens J, Van Ranst M, Van Damme P; RotaBel Study Group. 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.
- BackgroundBraeckman 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.
- BackgroundMatthijnssens 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)
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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
29 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 and Rotavirus Vaccines, run by GlaxoSmithKline at 29 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 11 inclusion and 8 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 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 PCR-confirmed rotavirus (RV) severe gastroenteritis (SGE) in children fully vaccinated with Rotarix or in unvaccinated children (time frame: More than 14 days after receipt of vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01177826, which also lists 3 linked publications.
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 3 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.