Rotavirus Severe GastroenteritisNCT00655187
Effectiveness of Human Rotavirus Vaccine, Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants
An observational study of Rotavirus Severe Gastroenteritis, run by GlaxoSmithKline at 1 site in Singapore.
Trial summary
This study aims to evaluate the effectiveness of Rotarix™ vaccine in the general population in Singapore by monitoring the overall reduction in RV SGE and also by assessing the direct protection offered by the vaccine in hospitalised infants through a case-control study. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Rotavirus Severe Gastroenteritis
- What is being tested?
- Collection of information and Collection of stool samples
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 1,270 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2008to Jul 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children less than 5 years of age, hospitalised with acute GE, living in Singapore served by the hospital participating in the study (KK Hospital) and whose parents/ guardians are willing to provide informed consent, will be considered as cases. Cases will be limited to those subjects who are born after 1 November 2005, aged at least 16 weeks and whose stool samples have been tested positive for rotavirus (RV). For each case, two controls hospitalised for acute disease with non-GE causes in the same hospital during the same period, will be included in the study after matching them by date of birth.
Who may be able to join
- A male or female child aged < 60 months at the time of admission (a child becomes ineligible on the day of its fifth birthday).
- Subject admitted with acute GE as an inpatient to the study site during the study period.
- Written informed consent obtained from the parent or guardian of the subject. Selection criteria for cases
- Cases will be limited to those surveillance subjects:
- who are born after 1 November 2005 (date of availability of Rotarix™ vaccination in Singapore),
- who are aged at least 16 weeks at the time of hospital admission.
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- whose stool samples are tested positive for RV. Selection criteria for controls
- All controls must satisfy the following criteria at study entry:
- Admitted for acute disease with non-GE causes in the same hospital as the case , with the closest admission date to the cases.
- Aged at least 16 weeks at the time of hospital admission.
- Born within a range of ± 2 weeks from the date of birth of cases. In case there is no suitable match, then the range would be extended to ± 4 weeks.
- Written informed consent obtained from the subject's parents/guardians.
Who cannot join
- For enrolment of surveillance subjects
- The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- The diagnoses at admission to the study site do not include acute GE.
- Children for whom stool samples are not available up to 48 hours after admission.
- The onset of GE is after 48 hours of admission to the hospital (i.e. nosocomial GE).
- Children with a history of chronic and genetic diseases. For selection of cases
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- In addition to the exclusion criteria for surveillance subjects, cases will not be selected if the following criterion applies:
- Subjects who had a previous episode of acute GE less than a week back i.e. recurrent GE episode.
- Subjects who have been already enrolled in the study.
- Subjects whose vaccination history could not be ascertained. For selection of controls
- The following criteria should be checked at the time of study entry. If any apply, the controls must not be included in the study:
- Child who has symptoms of GE on the day of interview of his/her parent or guardian or had an episode of GE within 14 days prior to the day of interview.
- Child who has been already enrolled in the study as case or control.
- The onset of GE occurs after admission at the hospital.
- Child whose vaccination history could not be ascertained.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case-control Study to Evaluate the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children < 5 Years of Age in KK Hospital, Singapore
This study aims to evaluate the effectiveness of Rotarix™ vaccine in the general population in Singapore by monitoring the overall reduction in RV SGE and also by assessing the direct protection offered by the vaccine in hospitalised infants through a case-control study.
Read the detailed description
This Protocol Posting has been updated following an amendment of the Protocol.
- Conditions
- Rotavirus Severe Gastroenteritis
- Being tested
- Collection of information, Collection of stool samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of informationOther
Information regarding demographic characteristics, medical history, previous participation in rotavirus clinical trials and vaccination history will be collected.
Collection of stool samplesProcedure or surgery
Stools samples will be collected during hospitalisation for RV testing and genotyping of RV positive samples.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Cases Receives: Other: Collection of information; Procedure: Collection of stool samples | |
| Group B | Controls Receives: Other: Collection of information |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the proportion of acute RV GE hospitalisations in children < 5 years of age.
Measured: At least one year
To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis (RV SGE) among children born after 1 November 2005 and aged at least 16 weeks.
Measured: At least one year
Secondary outcomes (4)
To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing hospitalisation for acute RV GE among children born after 1 November 2005 and aged at least 16 weeks.
Measured: At least one year
To determine the distributions of acute RV GE associated hospital admissions according to subject's age, gender and by month of year.
Measured: At least one year
To estimate the prevalence of RV genotypes in acute RV GE associated hospital admission.
Measured: At least one year
To review the trend of acute RV GE and acute GE admissions over the entire study period.
Measured: At least one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus Severe GastroenteritisStudies 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
- 1,270 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
- NCT00655187
- Sponsor's protocol ID
- 110467
- Status last verified
- May 2017
- First submitted
- 1 Apr 2008
- Last updated
- 30 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-control Study to Evaluate the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children < 5 Years of Age in KK Hospital, Singapore
- ClinicalTrials.gov ID
- NCT00655187
- Acronym / sponsor ID
- 110467
- Conditions
- Rotavirus Severe Gastroenteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,270 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Apr 2008 (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 evaluate the effectiveness of Rotarix™ vaccine in the general population in Singapore by monitoring the overall reduction in RV SGE and also by assessing the direct protection offered by the vaccine in hospitalised infants through a case-control study.
Detailed description
This Protocol Posting has been updated following an amendment of the Protocol.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Collection of information, Procedure: Collection of stool samplesCases |
| Group B | – | Other: Collection of informationControls |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children less than 5 years of age, hospitalised with acute GE, living in Singapore served by the hospital participating in the study (KK Hospital) and whose parents/ guardians are willing to provide informed consent, will be considered as cases. Cases will be limited to those subjects who are born after 1 November 2005, aged at least 16 weeks and whose stool samples have been tested positive for rotavirus (RV). For each case, two controls hospitalised for acute disease with non-GE causes in the same hospital during the same period, will be included in the study after matching them by date of birth.
Key inclusion criteria (12 listed)
- A male or female child aged < 60 months at the time of admission (a child becomes ineligible on the day of its fifth birthday).
- Subject admitted with acute GE as an inpatient to the study site during the study period.
- Written informed consent obtained from the parent or guardian of the subject. Selection criteria for cases
- who are born after 1 November 2005 (date of availability of Rotarix™ vaccination in Singapore),
- who are aged at least 16 weeks at the time of hospital admission.
Key exclusion criteria (15 listed)
- For enrolment of surveillance subjects
- The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- The diagnoses at admission to the study site do not include acute GE.
- Children for whom stool samples are not available up to 48 hours after admission.
- The onset of GE is after 48 hours of admission to the hospital (i.e. nosocomial GE).
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 |
|---|---|---|
| Collection of informationInformation regarding demographic characteristics, medical history, previous participation in rotavirus clinical trials and vaccination history will be collected. | Other | Group A, Group B |
| Collection of stool samplesStools samples will be collected during hospitalisation for RV testing and genotyping of RV positive samples. | Procedure or surgery | Group A |
Primary outcome
To estimate the proportion of acute RV GE hospitalisations in children < 5 years of age.
Time frame: At least one year
To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis (RV SGE) among children born after 1 November 2005 and aged at least 16 weeks.
Time frame: At least one year
4 secondary outcomes
To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing hospitalisation for acute RV GE among children born after 1 November 2005 and aged at least 16 weeks.
Time frame: At least one year
To determine the distributions of acute RV GE associated hospital admissions according to subject's age, gender and by month of year.
Time frame: At least one year
To estimate the prevalence of RV genotypes in acute RV GE associated hospital admission.
Time frame: At least one year
To review the trend of acute RV GE and acute GE admissions over the entire study period.
Time frame: At least one year
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 30 May 2017.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotavirus Severe Gastroenteritis, run by GlaxoSmithKline at 1 site in Singapore.
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 12 inclusion and 15 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
To estimate the proportion of acute RV GE hospitalisations in children < 5 years of age. (time frame: At least one year). The study lists 2 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 30 May 2017.