Infections, RotavirusNCT00653198
Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama
An observational study of Infections, Rotavirus, run by GlaxoSmithKline at 1 site in Panama.
Trial summary
This study aims to estimate the effectiveness of Rotarix™ vaccine which is used nationwide as a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised children born after 1 March 2006, which corresponds to the date of introduction of Rotarix™ in the national immunization program. Read more about this study
- Who is it for?
- Ages 12 weeks and older
- Conditions the study is for
- Infections, Rotavirus
- How many people
- 885 participants
- Where
- 1 sitePanama
- Study dates
- 19 Mar 2008to 18 Mar 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: Cases will include those children born after 1 March 2006, at least 12 weeks of age and hospitalised for RV SGE in the study hospital, during the designated study period. For each case, three hospital controls and three neighbourhood controls will be included in the study, after matching by date of birth. Hospital controls will be children hospitalised for non-GE causes in the study hospital during the same time period as the case. Neighbourhood controls will be children without any symptoms of GE or SGE, and residing in the same area as the case at least for three consecutive months.
Who may be able to join
- A male or female child born after 1 March 2006 (which corresponds to the date of introduction of Rotarix™ in the EPI) and at least 12 weeks of age.
- Subject admitted to the study hospital for SGE (refer to the glossary) during the study period.
- Onset of SGE <= 14 days prior to admission.
- Laboratory confirmed (i.e. by ELISA at the hospital laboratory) RV positive stool sample at hospital admission or during the first 48 hours of hospitalisation. Note: This criterion is applicable only for cases.
- Written informed consent obtained from the parent or guardian of the subject.
- Admitted for non-GE causes at the same hospital as the case. Note: This criterion is applicable to hospital controls only.
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- Living in the same neighbourhood as the case for at least three consecutive months. Note: This criterion is applicable to neighbourhood controls only.
- At least 12 weeks of age and being 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 would be extended to ± 4 weeks.
- Written informed consent obtained from the parent or guardian of the child.
Who cannot join
- Subject has previously participated as case or control in this study.
- Hospitalisation is unrelated to GE.
- Onset of SGE > 48 hours after admission to the hospital (nosocomial infections).
- For hospital controls: Child who has symptoms of GE during current hospitalisation or on the day of interview of his/her parent or guardian.
- OR
- For neighbourhood controls: Child who has symptoms of GE on the day of interview of his/her parent or guardian.
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- 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. Note: This criterion is applicable to neighbourhood controls only
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hospital-based, Case-control Study to Assess the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children Born After 1 March 2006 and at Least 12 Weeks of Age, in Panama
This study aims to estimate the effectiveness of Rotarix™ vaccine which is used nationwide as a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised children born after 1 March 2006, which corresponds to the date of introduction of Rotarix™ in the national immunization program.
- Conditions
- Infections, Rotavirus
- Being tested
- No intervention
- Keywords
- Rotavirus severe gastroenteritis (RV SGE)
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| A | Cases Receives: Other: No intervention | |
| B | Controls Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of RV GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE.
Secondary outcomes (1)
Occurrence of acute GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study start19 Mar 2008
- Primary completion18 Mar 2011
- Study completion18 Mar 2011
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
- 885 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
- NCT00653198
- Sponsor's protocol ID
- 104676
- Status last verified
- Sep 2017
- First submitted
- 19 Mar 2008
- Last updated
- 5 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-based, Case-control Study to Assess the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children Born After 1 March 2006 and at Least 12 Weeks of Age, in Panama
- ClinicalTrials.gov ID
- NCT00653198
- Acronym / sponsor ID
- 104676
- Conditions
- Infections, Rotavirus
- Keywords
- Rotavirus severe gastroenteritis (RV SGE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 885 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2008 (actual)
- Primary completion
- 18 Mar 2011 (actual)
- Study completion
- 18 Mar 2011 (actual)
- First posted
- 4 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 estimate the effectiveness of Rotarix™ vaccine which is used nationwide as a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised children born after 1 March 2006, which corresponds to the date of introduction of Rotarix™ in the national immunization program.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: No interventionCases |
| B | – | Other: No interventionControls |
Who may qualify
- Ages
- 12 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases will include those children born after 1 March 2006, at least 12 weeks of age and hospitalised for RV SGE in the study hospital, during the designated study period. For each case, three hospital controls and three neighbourhood controls will be included in the study, after matching by date of birth. Hospital controls will be children hospitalised for non-GE causes in the study hospital during the same time period as the case. Neighbourhood controls will be children without any symptoms of GE or SGE, and residing in the same area as the case at least for three consecutive months.
Key inclusion criteria (9 listed)
- A male or female child born after 1 March 2006 (which corresponds to the date of introduction of Rotarix™ in the EPI) and at least 12 weeks of age.
- Subject admitted to the study hospital for SGE (refer to the glossary) during the study period.
- Onset of SGE <= 14 days prior to admission.
- Laboratory confirmed (i.e. by ELISA at the hospital laboratory) RV positive stool sample at hospital admission or during the first 48 hours of hospitalisation. Note: This criterion is applicable only for cases.
- Written informed consent obtained from the parent or guardian of the subject.
Key exclusion criteria (9 listed)
- Subject has previously participated as case or control in this study.
- Hospitalisation is unrelated to GE.
- Onset of SGE > 48 hours after admission to the hospital (nosocomial infections).
- For hospital controls: Child who has symptoms of GE during current hospitalisation or on the day of interview of his/her parent or guardian.
- OR
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 |
|---|---|---|
| No intervention | Other | A, B |
Primary outcome
Occurrence of RV GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE.
1 secondary outcome
Occurrence of acute GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE.
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 5 Sep 2017.
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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 Infections, Rotavirus, run by GlaxoSmithKline at 1 site in Panama.
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 9 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: finished, as of the sponsor's last update on 5 Sep 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 Panama. 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 RV GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE.. 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 5 Sep 2017.