Infections, RotavirusNCT01435967
Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™
An observational study of Infections, Rotavirus, run by GlaxoSmithKline at 8 sites in Belgium.
Trial summary
The aim of this study is to monitor any impact in the change from the lyophilised formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus gastroenteritis. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- Data collection
- Type of treatment
- Vaccines
- How many people
- 1 participants
- Where
- 8 sitesBelgium
- Study dates
- Sep 2011to Sep 2014
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children hospitalised due to laboratory confirmed rotavirus gastroenteritis in approximately 8 hospitals across Belgium.
Who may be able to join
- All subjects must satisfy ALL the following criteria at study entry:
- Child aged ≤5 years with opportunity to receive lyophilised or liquid formulation of Rotarix™;
- Hospitalised at one of the participating centres in Belgium;
- A stool sample has been provided for a rotavirus detection test during the study period;
- Laboratory test result of rotavirus is available.
Who cannot join
- None.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
GSK Investigational Site
Antwerp, 2020
GSK Investigational Site
Bonheiden, 2820
GSK Investigational Site
Charleroi, 6000
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Hasselt, 3500
GSK Investigational Site
Ieper, 8900
GSK Investigational Site
Jette, 1090
GSK Investigational Site
Yvoir, 5330
About this study
Official title: Observational, Ecological, Database Study on Epidemiology of Hospitalisations With Rotavirus Gastroenteritis Confirmed in Children Aged ≤5 Years, and Any Impact in the Change From Lyophilised to Liquid Formulation of Rotarix™, in Belgium
The aim of this study is to monitor any impact in the change from the lyophilised formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus gastroenteritis. This is planned to be assessed by comparing trends of hospitalisations due to laboratory confirmed rotavirus gastroenteritis in children <=5 years of age, before and after introduction of the liquid formulation of the vaccine in Belgium.
- Conditions
- Infections, Rotavirus
- Being tested
- Data collection
- Keywords
- Rotarix™, Observational, ecological
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collected when only the lyophilised formulation of Rotarix was in use (which is considered as baseline) will be specifically compared to data collected post the introduction of the liquid formulation. The results will also be compared to available vaccine coverage data for those rotavirus vaccines being used in Belgium.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Children aged <=5 years in Belgium, with opportunity to receive Rotarix, requiring hospitalisation during which rotavirus detection test was performed and with available results. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™
Measured: up to 2 years post-introduction of liquid formulation of Rotarix™.
Secondary outcomes (4)
Occurrence of rotavirus detected by laboratory tests in children of various age, gender and location (centre and region).
Measured: up to 2 years post-introduction of liquid formulation of Rotarix™.
Occurrence of rotavirus detected by laboratory tests at a specific time (month and year).
Measured: up to 2 years post-introduction of liquid formulation of Rotarix™.
Occurrence of rotavirus detected by various types of rotavirus laboratory tests.
Measured: up to 2 years post-introduction of liquid formulation of Rotarix™.
Occurrence of rotavirus vaccination with a specific brand of vaccine (Rotarix and RotaTeq) among children ≤5 years of age in the Belgian population.
Measured: up to 2 years post-introduction of liquid formulation of Rotarix™.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 1 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
- NCT01435967
- Sponsor's protocol ID
- 114061
- Status last verified
- Mar 2015
- First submitted
- 9 Sep 2011
- Last updated
- 9 Mar 2015
- Results posted
- No
Publications
Raes M, Strens D, Kleintjens J, Biundo E, Morel T, Vyse A. Epidemiological trends for hospital admissions for acute rotavirus gastroenteritis in Belgium following the introduction of routine rotavirus vaccination and the subsequent switch from lyophilized to liquid formulation of Rotarix. Epidemiol Infect. 2016 Oct;144(14):3017-3024. doi: 10.1017/S0950268816001151. Epub 2016 Jul 4.
PubMed 27373141
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Ecological, Database Study on Epidemiology of Hospitalisations With Rotavirus Gastroenteritis Confirmed in Children Aged ≤5 Years, and Any Impact in the Change From Lyophilised to Liquid Formulation of Rotarix™, in Belgium
- ClinicalTrials.gov ID
- NCT01435967
- Acronym / sponsor ID
- 114061
- Conditions
- Infections, Rotavirus
- Keywords
- Rotarix™, Observational, ecological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Sep 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 aim of this study is to monitor any impact in the change from the lyophilised formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus gastroenteritis. This is planned to be assessed by comparing trends of hospitalisations due to laboratory confirmed rotavirus gastroenteritis in children <=5 years of age, before and after introduction of the liquid formulation of the vaccine in Belgium.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: Data collectionChildren aged <=5 years in Belgium, with opportunity to receive Rotarix, requiring hospitalisation during which rotavirus detection test was performed and with available results. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children hospitalised due to laboratory confirmed rotavirus gastroenteritis in approximately 8 hospitals across Belgium.
Key inclusion criteria (5 listed)
- Child aged ≤5 years with opportunity to receive lyophilised or liquid formulation of Rotarix™;
- Hospitalised at one of the participating centres in Belgium;
- A stool sample has been provided for a rotavirus detection test during the study period;
- Laboratory test result of rotavirus is available.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Data collectionData collected when only the lyophilised formulation of Rotarix was in use (which is considered as baseline) will be specifically compared to data collected post the introduction of the liquid formulation. The results will also be compared to available vaccine coverage data for those rotavirus vaccines being used in Belgium. | Other | Cohort A |
Primary outcome
Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™
Time frame: up to 2 years post-introduction of liquid formulation of Rotarix™.
4 secondary outcomes
Occurrence of rotavirus detected by laboratory tests in children of various age, gender and location (centre and region).
Time frame: up to 2 years post-introduction of liquid formulation of Rotarix™.
Occurrence of rotavirus detected by laboratory tests at a specific time (month and year).
Time frame: up to 2 years post-introduction of liquid formulation of Rotarix™.
Occurrence of rotavirus detected by various types of rotavirus laboratory tests.
Time frame: up to 2 years post-introduction of liquid formulation of Rotarix™.
Occurrence of rotavirus vaccination with a specific brand of vaccine (Rotarix and RotaTeq) among children ≤5 years of age in the Belgian population.
Time frame: up to 2 years post-introduction of liquid formulation of Rotarix™.
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 9 Mar 2015.
- Derived from this study: PubMed 27373141Raes M, Strens D, Kleintjens J, Biundo E, Morel T, Vyse A. Epidemiological trends for hospital admissions for acute rotavirus gastroenteritis in Belgium following the introduction of routine rotavirus vaccination and the subsequent switch from lyophilized to liquid formulation of Rotarix. Epidemiol Infect. 2016 Oct;144(14):3017-3024. doi: 10.1017/S0950268816001151. Epub 2016 Jul 4.
Related trials for Infections, Rotavirus
Active, not recruitingPhase 1
CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults
Rotavirus Infections
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Active, not recruitingPhase 3
The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
Rotavirus Infection of Children
Recruiting
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock
Active, not recruitingPhase 2
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
Rotavirus Infections, Rotavirus Gastroenteritis
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
8 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 8 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 5 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 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™ (time frame: up to 2 years post-introduction of liquid formulation of Rotarix™.). 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 NCT01435967, which also lists 1 linked publication.
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 9 Mar 2015.