Infections, RotavirusNCT01636739
Special Drug Use Investigation for ROTARIX®
An observational study of Infections, Rotavirus, run by GlaxoSmithKline.
Trial summary
This study aims to determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, 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
- Pill or oral medicine
- How many people
- 10,982 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Aug 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 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.
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 drug use investigation of Oral Rotarix will be excluded.
About this study
Official title: Special Drug Use Investigation for ROTARIX
This study aims to determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in Japan.
Read the detailed description
This is non-interventional study conducted in one group received Oral Rotarix®.
- Conditions
- Infections, Rotavirus
- Being tested
- Oral Rotarix®, Data collection
- Keywords
- Intussusceptions, Special Drug Use Investigation, Rotavirus
- Medical subject headings
- Rotavirus Infections, Intussusception
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
Additional information on intussusception will be collected through interview and by phone-contact.
| 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.
Determination of the incidence of IS
Measured: During the 31-day (Day 0 -Day 30) observation period after each vaccination
Determination of the incidence of IS
Measured: On the 1 year birthday of the subject
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 startJul 2012
- Primary completionAug 2015
- Study completionAug 2015
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
- 10,982 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
- NCT01636739
- Sponsor's protocol ID
- 115927
- Status last verified
- Oct 2015
- First submitted
- 5 Jul 2012
- Last updated
- 2 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation for ROTARIX
- ClinicalTrials.gov ID
- NCT01636739
- Acronym / sponsor ID
- 115927
- Conditions
- Infections, Rotavirus
- Keywords
- Intussusceptions, Special Drug Use Investigation, Rotavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,982 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (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 determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in Japan.
Detailed description
This is non-interventional study conducted in one group received Oral 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.
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 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 collectionAdditional information on intussusception will be collected through interview and by phone-contact. | Other | Rota Group |
Primary outcome
Determination of the incidence of IS
Time frame: During the 31-day (Day 0 -Day 30) observation period after each vaccination
Determination of the incidence of IS
Time frame: On the 1 year birthday of the subject
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 2 Nov 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 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 2 Nov 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?
Determination of the incidence of IS (time frame: During the 31-day (Day 0 -Day 30) 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 2 Nov 2015.