Rotavirus GastroenteritisNCT01177657
Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil
An observational study of Rotavirus Gastroenteritis, run by GlaxoSmithKline at 1 site in Brazil.
Trial summary
The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil. Read more about this study
- Who is it for?
- Ages 12 weeks and older
- Conditions the study is for
- Rotavirus Gastroenteritis
- What is being tested?
- Stool sampling
- Type of treatment
- Surgery or procedure
- How many people
- 1,944 participants
- Where
- 1 siteBrazil
- Study dates
- May 2008to May 2011
- 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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Gastroenteritis Cohort: Cases will include children born after 6 March 2006, at least 12 weeks of age and hospitalized for rotavirus severe gastroenteritis the study clinics/hospitals, during the designated study period, Hospital control cohort: Children hospitalized for non gastroenteritis causes, Neighbourhood control cohort: Children without any symptoms of gastroenteritis or severe gastroenteritis.
Who may be able to join
- For cases:
- A male or female child born after 6 March 2006 and at least 12 weeks of age.
- Subject admitted to the study clinics/hospitals for severe gastroenteritis during the study period.
- Onset of severe gastroenteritis ≤ 14 days prior to admission.
- Laboratory confirmed rotavirus positive stool sample at hospital admission or during the first 48 hours of hospitalization.
- Written informed consent obtained from the parent or guardian of the subject.
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- For controls:
- Admitted for non-gastroenteritis causes at the same clinic/hospital as the case.
- Living in the same neighbourhood as the case for at least three consecutive months without any symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/ her parents/ guardians.
- Being born within +- 2 weeks from the date of birth of the case. If the number required is not available, then the range would be extended to +- 4 weeks, and ultimately up to +- 6 weeks for hospital controls. For neighbourhood controls, the range may be extended to +- 8 weeks.
- Written informed consent obtained from the parent or guardian of the child.
Who cannot join
- For cases:
- Subject has previously participated as case or control in this study.
- Onset of severe gastroenteritis > 48 hours after admission to the hospital (nosocomial infections).
- For controls:
- For hospital controls: Child who has symptoms of gastroenteritis during current hospitalization or on the day of interview of his/her parent or guardian or for neighbourhood controls: Child who has symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/her parent or guardian.
- Exclude children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus influenzae type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B.
- Child has participated in the past as a case or control in this study.
- Child living in the same house as the case
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 Hospitalized Children Born After 6 March 2006 and at Least 12 Weeks of Age, in Belem, Brazil
The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.
Read the detailed description
The study will be comprised of two parts: Case-control study and Rotavirus strain surveillance.
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- Stool sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool samplingProcedure or surgery
Stool samples collected and checked for the presence of rotavirus
| Study group | Role | What they receive |
|---|---|---|
| Gastroenteritis cohort | Children born after 6 March 2006, at least 12 weeks of age and hospitalized for rotavirus severe gastroenteritis Receives: Procedure: Stool sampling | |
| Hospital control cohort | Children hospitalized for non gastroenteritis causes | |
| Neighbourhood control cohort | Children without any symptoms of gastroenteritis or severe gastroenteritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of Enzyme Linked Immunosorbent Assay (ELISA) confirmed rotavirus severe gastroenteritis in children fully vaccinated with Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children
Measured: Average time frame: 12-24 months
Secondary outcomes (3)
Risk of ELISA confirmed rotavirus severe gastroenteritis in children vaccinated with at least one dose of Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children
Measured: Average time frame: 12-24 months
Occurrence of severe gastroenteritis among children admitted to study clinics/hospitals for severe gastroenteritis
Measured: Average time frame: 12-24 months
Occurrence of rotavirus serotypes among children
Measured: Average time frame: 36 months
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 startMay 2008
- Primary completionMay 2011
- Study completionMay 2011
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 Rotavirus 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
- 1,944 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
- NCT01177657
- Sponsor's protocol ID
- 111562
- Status last verified
- Nov 2012
- First submitted
- 5 Aug 2010
- Last updated
- 19 Nov 2012
- Results posted
- No
Publications
Justino MC, Linhares AC, Lanzieri TM, Miranda Y, Mascarenhas JD, Abreu E, Guerra SF, Oliveira AS, da Silva VB, Sanchez N, Meyer N, Shafi F, Ortega-Barria E, Soriano-Gabarro M, Colindres RE. Effectiveness of the monovalent G1P[8] human rotavirus vaccine against hospitalization for severe G2P[4] rotavirus gastroenteritis in Belem, Brazil. Pediatr Infect Dis J. 2011 May;30(5):396-401. doi: 10.1097/INF.0b013e3182055cc2.
PubMed 21150692
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. 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 Hospitalized Children Born After 6 March 2006 and at Least 12 Weeks of Age, in Belem, Brazil
- ClinicalTrials.gov ID
- NCT01177657
- Acronym / sponsor ID
- 111562
- Conditions
- Rotavirus Gastroenteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,944 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (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 estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.
Detailed description
The study will be comprised of two parts: Case-control study and Rotavirus strain surveillance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastroenteritis cohort | – | Procedure: Stool samplingChildren born after 6 March 2006, at least 12 weeks of age and hospitalized for rotavirus severe gastroenteritis |
| Hospital control cohort | – | –Children hospitalized for non gastroenteritis causes |
| Neighbourhood control cohort | – | –Children without any symptoms of gastroenteritis or severe gastroenteritis |
Who may qualify
- Ages
- 12 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Gastroenteritis Cohort: Cases will include children born after 6 March 2006, at least 12 weeks of age and hospitalized for rotavirus severe gastroenteritis the study clinics/hospitals, during the designated study period, Hospital control cohort: Children hospitalized for non gastroenteritis causes, Neighbourhood control cohort: Children without any symptoms of gastroenteritis or severe gastroenteritis.
Key inclusion criteria (11 listed)
- A male or female child born after 6 March 2006 and at least 12 weeks of age.
- Subject admitted to the study clinics/hospitals for severe gastroenteritis during the study period.
- Onset of severe gastroenteritis ≤ 14 days prior to admission.
- Laboratory confirmed rotavirus positive stool sample at hospital admission or during the first 48 hours of hospitalization.
- Written informed consent obtained from the parent or guardian of the subject.
Key exclusion criteria (8 listed)
- Subject has previously participated as case or control in this study.
- Onset of severe gastroenteritis > 48 hours after admission to the hospital (nosocomial infections).
- For hospital controls: Child who has symptoms of gastroenteritis during current hospitalization or on the day of interview of his/her parent or guardian or for neighbourhood controls: Child who has symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/her parent or guardian.
- Exclude children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus influenzae type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B.
- Child has participated in the past as a case or control in this study.
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 samplingStool samples collected and checked for the presence of rotavirus | Procedure or surgery | Gastroenteritis cohort |
Primary outcome
Risk of Enzyme Linked Immunosorbent Assay (ELISA) confirmed rotavirus severe gastroenteritis in children fully vaccinated with Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children
Time frame: Average time frame: 12-24 months
3 secondary outcomes
Risk of ELISA confirmed rotavirus severe gastroenteritis in children vaccinated with at least one dose of Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children
Time frame: Average time frame: 12-24 months
Occurrence of severe gastroenteritis among children admitted to study clinics/hospitals for severe gastroenteritis
Time frame: Average time frame: 12-24 months
Occurrence of rotavirus serotypes among children
Time frame: Average time frame: 36 months
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 19 Nov 2012.
- Background: PubMed 21150692Justino MC, Linhares AC, Lanzieri TM, Miranda Y, Mascarenhas JD, Abreu E, Guerra SF, Oliveira AS, da Silva VB, Sanchez N, Meyer N, Shafi F, Ortega-Barria E, Soriano-Gabarro M, Colindres RE. Effectiveness of the monovalent G1P[8] human rotavirus vaccine against hospitalization for severe G2P[4] rotavirus gastroenteritis in Belem, Brazil. Pediatr Infect Dis J. 2011 May;30(5):396-401. doi: 10.1097/INF.0b013e3182055cc2.
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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
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 Gastroenteritis, run by GlaxoSmithKline at 1 site in Brazil.
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 19 Nov 2012. 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 Brazil. 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?
Risk of Enzyme Linked Immunosorbent Assay (ELISA) confirmed rotavirus severe gastroenteritis in children fully vaccinated with Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children (time frame: Average time frame: 12-24 months). 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 NCT01177657, 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 19 Nov 2012.