Infections, RotavirusNCT01636193
Drug Use Investigation for ROTARIX®
An observational study of Infections, Rotavirus, run by GlaxoSmithKline.
Trial summary
This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- Oral Rotarix® and Data collection
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 1,607 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis as part of routine immunisation programme.
Who may be able to join
- Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation.
Who cannot join
- All infants included in the special drug use investigation of Oral Rotarix will be excluded.
About this study
Official title: Drug Use Investigation for ROTARIX
This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.
Read the detailed description
This is non-interventional study conducted in one group received Oral Rotarix®. This surveillance is abbreviated as SMILER (Surveillance and Monitoring In Living clinical Experience for Rotarix).
- Conditions
- Infections, Rotavirus
- Being tested
- Oral Rotarix®, Data collection
- Keywords
- Rotavirus, Rotarix, Drug Use Investigation, Safety
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Rotarix®Biological
2 doses administered orally.
Data collectionOther
Safety data will be collected through the check of health observation diary and interview of vaccinee's parent.
| Study group | Role | What they receive |
|---|---|---|
| Rota Group | Subjects will receive Rotarix® as per routine practice. Receives: Biological: Oral Rotarix®; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse events under clinical practice.
Measured: During the 31-day observation period after each vaccination.
Occurrence of typical symptoms of intussusceptions and bloody stool.
Measured: During the 31-day observation period after each vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2014
- Study completionSep 2014
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,607 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
- NCT01636193
- Sponsor's protocol ID
- 115926
- Status last verified
- Aug 2015
- First submitted
- 25 Jun 2012
- Last updated
- 17 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation for ROTARIX
- ClinicalTrials.gov ID
- NCT01636193
- Acronym / sponsor ID
- 115926
- Conditions
- Infections, Rotavirus
- Keywords
- Rotavirus, Rotarix, Drug Use Investigation, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,607 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Jul 2012 (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 assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.
Detailed description
This is non-interventional study conducted in one group received Oral Rotarix®. This surveillance is abbreviated as SMILER (Surveillance and Monitoring In Living clinical Experience for Rotarix).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rota Group | – | Biological: Oral Rotarix®, Other: Data collectionSubjects will receive Rotarix® as per routine practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis as part of routine immunisation programme.
Key inclusion criteria (1 listed)
- Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation.
Key exclusion criteria (1 listed)
- All infants included in the special drug use investigation of Oral Rotarix will be excluded.
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 |
|---|---|---|
| Oral Rotarix®2 doses administered orally. | Biological | Rota Group |
| Data collectionSafety data will be collected through the check of health observation diary and interview of vaccinee's parent. | Other | Rota Group |
Primary outcome
Occurrence of Adverse events under clinical practice.
Time frame: During the 31-day observation period after each vaccination.
Occurrence of typical symptoms of intussusceptions and bloody stool.
Time frame: During the 31-day observation period after each vaccination.
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 17 Aug 2015.
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
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 1 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 17 Aug 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 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 Adverse events under clinical practice. (time frame: During the 31-day observation period after each vaccination.). 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 17 Aug 2015.