Infections, RotavirusNCT01978223
Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
An observational study of Infections, Rotavirus, run by GlaxoSmithKline.
Trial summary
This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and < 5 years, in Venezuela and to assess the current disease burden after introduction of the vaccine. Read more about this study
- Who is it for?
- Ages 12 weeks to 5 years
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- Stool sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2015
- 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 12 weeks to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 12 weeks to < 5 years, hospitalised for SGE in the study hospitals.
Who may be able to join
- For SGE subjects:
- A male or female child aged 12 weeks to < 5 years at the time of hospital admission/ ED stay. The subject becomes ineligible on the fifth birthday.
- Subject admitted to (or who will have an ED stay at) the study hospital(s) for SGE during the study period.
- Onset of SGE ≤ 14 days prior to admission/ ED stay.
- Written/thumb printed informed consent obtained from the parent(s)/legally acceptable representative(s) (LAR (s)) of the subject.
- For Cases:
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- Laboratory confirmed (i.e. by ELISA) RV-positive stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.
- For Controls:
- Subject admitted to (or who will have an ED stay at) the same study hospital(s) for SGE as that of the case during the study period.
- Laboratory confirmed (i.e. by ELISA) RV-negative stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.
- Subjects born within ± 2 weeks from the date of birth of the case.
Who cannot join
- For SGE subjects:
- Child in care.
- Hospitalisation is unrelated to GE.
- Onset of SGE > 48 hours after admission to (or ED stay at) the hospital.
- Subject has digestive tube anomalies, chronic gastrointestinal disease or uncorrected congenital abnormalities.
- Subject with immunodeficiency.
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- Subjects who live out of the federative entity where hospital(s) are located.
- For Controls:
- Subject has previously participated as case in this study.
About this study
Official title: Case-control Study to Evaluate the Vaccine Effectiveness of RotarixTM Against Rotavirus Severe Gastroenteritis Among Hospitalised Children Aged 12 Weeks to < 5 Years, in Venezuela
This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and < 5 years, in Venezuela and to assess the current disease burden after introduction of the vaccine.
Read the detailed description
The data generated in this study will be useful for public health officers and policy makers in confirming the country-wide public health benefit of Rotarix™.
No vaccine will be administered during this study.
- Conditions
- Infections, Rotavirus
- Being tested
- Stool sample collection
- Keywords
- Rotarix™, Case-control, Venezuela, Vaccine effectiveness, Rotavirus Severe Gastroenteritis, Children, Hospitalised
- 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 sample collectionProcedure or surgery
Stool samples will be collected from all children enrolled in the study, within 48 hours of admission to the hospital/ ED. Stool samples will be tested to determine the presence or absence of rotavirus (RV). Additionally, for RV-positive cases, the stool samples will be tested to determine the RV genotypes.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Children hospitalised for SGE, aged 12 weeks to < 5 years at the time of hospital admission/ED stay and whose stool samples test positive for RV by enzyme linked immunosorbent assay (ELISA) at a GSK designated laboratory. Receives: Procedure: Stool sample collection | |
| Controls | Children hospitalised for SGE, aged 12 weeks to < 5 years at the time of hospital admission/ ED stay, whose stool samples test negative for RV by enzyme linked immunosorbent assay at a GSK designated laboratory and who will be matched to the cases by date of birth and the hospital of admission/ ED stay. Receives: Procedure: Stool sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full vaccination status of Rotarix™ (2 doses) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).
Measured: During hospitalisation and after discharge (approximately 12 months from study initiation).
Secondary outcomes (8)
Full/partial vaccination status (at least one dose of Rotarix™) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).
Measured: During hospitalisation and after discharge (approximately 12 months from study initiation).
Occurrence of specific RV genotype among the enrolled RV SGE children with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine is administered at least 2 weeks before hospitalisation).
Measured: During hospitalisation and after discharge (approximately 12 months from study initiation).
Occurrence of RV SGE in children by age at hospitalisation with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine administered at least 2 weeks before hospitalisation).
Measured: During hospitalisation and after discharge (approximately 12 months from study initiation).
Occurrence of RV SGE in children by severity with assessment of severity of RV SGE cases by the Vesikari scale.
Measured: During hospitalisation and after discharge (approximately 12 months from study initiation).
Occurrence of SGE [≤14 days prior to admission/ Emergency Department (ED) stay] among all hospitalised children.
Measured: During hospitalisation and after discharge (approximately 12 months from study initiation).
Occurrence of RV SGE hospital admissions/ ED stays among children hospitalised at the study hospital(s) for SGE.
Measured: At hospital admission/ ED stay or during the first 48 hours of hospitalisation.
Occurrence of RV SGE admissions/ ED stays by age of the child (at hospitalisation) and month of year.
Measured: During hospitalisation and after discharge (approximately 12 months from study initiation).
Occurrence of RV genotypes among children admitted to (or who have had an ED stay at) the study hospital(s) for SGE.
Measured: During hospitalisation and after discharge (approximately 12 months from study initiation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: As vaccine coverage rates have drastically improved in Venezuela, the study lost its objective to show positive impact of the vaccine to stimulate higher usage
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-control
- Time perspective
- Prospective
- Enrolment
- 0 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
- NCT01978223
- Sponsor's protocol ID
- 116494
- Status last verified
- Mar 2015
- First submitted
- 31 Oct 2013
- Last updated
- 9 Mar 2015
- Results posted
- No
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
- Case-control Study to Evaluate the Vaccine Effectiveness of RotarixTM Against Rotavirus Severe Gastroenteritis Among Hospitalised Children Aged 12 Weeks to < 5 Years, in Venezuela
- ClinicalTrials.gov ID
- NCT01978223
- Acronym / sponsor ID
- 116494
- Conditions
- Infections, Rotavirus
- Keywords
- Rotarix™, Case-control, Venezuela, Vaccine effectiveness, Rotavirus Severe Gastroenteritis, Children, Hospitalised
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: As vaccine coverage rates have drastically improved in Venezuela, the study lost its objective to show positive impact of the vaccine to stimulate higher usage
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Nov 2013 (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.
This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and < 5 years, in Venezuela and to assess the current disease burden after introduction of the vaccine.
Detailed description
The data generated in this study will be useful for public health officers and policy makers in confirming the country-wide public health benefit of Rotarix™.
No vaccine will be administered during this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Procedure: Stool sample collectionChildren hospitalised for SGE, aged 12 weeks to < 5 years at the time of hospital admission/ED stay and whose stool samples test positive for RV by enzyme linked immunosorbent assay (ELISA) at a GSK designated laboratory. |
| Controls | – | Procedure: Stool sample collectionChildren hospitalised for SGE, aged 12 weeks to < 5 years at the time of hospital admission/ ED stay, whose stool samples test negative for RV by enzyme linked immunosorbent assay at a GSK designated laboratory and who will be matched to the cases by date of birth and the hospital of admission/ ED stay. |
Who may qualify
- Ages
- 12 weeks to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 12 weeks to < 5 years, hospitalised for SGE in the study hospitals.
Key inclusion criteria (11 listed)
- A male or female child aged 12 weeks to < 5 years at the time of hospital admission/ ED stay. The subject becomes ineligible on the fifth birthday.
- Subject admitted to (or who will have an ED stay at) the study hospital(s) for SGE during the study period.
- Onset of SGE ≤ 14 days prior to admission/ ED stay.
- Written/thumb printed informed consent obtained from the parent(s)/legally acceptable representative(s) (LAR (s)) of the subject.
- Laboratory confirmed (i.e. by ELISA) RV-positive stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.
Key exclusion criteria (9 listed)
- Child in care.
- Hospitalisation is unrelated to GE.
- Onset of SGE > 48 hours after admission to (or ED stay at) the hospital.
- Subject has digestive tube anomalies, chronic gastrointestinal disease or uncorrected congenital abnormalities.
- Subject with immunodeficiency.
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 sample collectionStool samples will be collected from all children enrolled in the study, within 48 hours of admission to the hospital/ ED. Stool samples will be tested to determine the presence or absence of rotavirus (RV). Additionally, for RV-positive cases, the stool samples will be tested to determine the RV genotypes. | Procedure or surgery | Cases, Controls |
Primary outcome
Full vaccination status of Rotarix™ (2 doses) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).
Time frame: During hospitalisation and after discharge (approximately 12 months from study initiation).
8 secondary outcomes
Full/partial vaccination status (at least one dose of Rotarix™) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).
Time frame: During hospitalisation and after discharge (approximately 12 months from study initiation).
Occurrence of specific RV genotype among the enrolled RV SGE children with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine is administered at least 2 weeks before hospitalisation).
Time frame: During hospitalisation and after discharge (approximately 12 months from study initiation).
Occurrence of RV SGE in children by age at hospitalisation with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine administered at least 2 weeks before hospitalisation).
Time frame: During hospitalisation and after discharge (approximately 12 months from study initiation).
Occurrence of RV SGE in children by severity with assessment of severity of RV SGE cases by the Vesikari scale.
Time frame: During hospitalisation and after discharge (approximately 12 months from study initiation).
Occurrence of SGE [≤14 days prior to admission/ Emergency Department (ED) stay] among all hospitalised children.
Time frame: During hospitalisation and after discharge (approximately 12 months from study initiation).
Occurrence of RV SGE hospital admissions/ ED stays among children hospitalised at the study hospital(s) for SGE.
Time frame: At hospital admission/ ED stay or during the first 48 hours of hospitalisation.
Occurrence of RV SGE admissions/ ED stays by age of the child (at hospitalisation) and month of year.
Time frame: During hospitalisation and after discharge (approximately 12 months from study initiation).
Occurrence of RV genotypes among children admitted to (or who have had an ED stay at) the study hospital(s) for SGE.
Time frame: During hospitalisation and after discharge (approximately 12 months from study initiation).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Rotavirus, run by GlaxoSmithKline.
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 9 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Full vaccination status of Rotarix™ (2 doses) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls). (time frame: During hospitalisation and after discharge (approximately 12 months from study initiation).). 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 9 Mar 2015.