Rotavirus InfectionsNCT01357174
ROTATEQ™ Post-Marketing Surveillance in the Philippines
An observational study of Rotavirus Infections and Gastroenteritis, run by Merck Sharp & Dohme LLC.
Trial summary
This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infections, Gastroenteritis
- Type of treatment
- Vaccines
- How many people
- 915 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Sep 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 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants in the Philippines who received ROTATEQ.™ Information will be provided by the physicians who administered the vaccine.
Who may be able to join
- Received ROTATEQ™
Who cannot join
None listed.
About this study
Official title: Protocol for ROTATEQ™ Post-Marketing Surveillance
This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.
- Conditions
- Rotavirus Infections, Gastroenteritis
- Medical subject headings
- Rotavirus Infections, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Infants who were vaccinated with ROTATEQ™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events following administration of ROTATEQ™
Measured: Three-year period following vaccine marketing approval (August 2007 to August 2010)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startOct 2007
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Merck Sharp \& Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Retrospective
- Enrolment
- 915 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357174
- Sponsor's protocol ID
- V260-046
- Status last verified
- Oct 2015
- First submitted
- 18 May 2011
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for ROTATEQ™ Post-Marketing Surveillance
- ClinicalTrials.gov ID
- NCT01357174
- Acronym / sponsor ID
- V260-046
- Conditions
- Rotavirus Infections, Gastroenteritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Merck Sharp \& Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study
- Enrolment
- 915 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 20 May 2011 (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 will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | –Infants who were vaccinated with ROTATEQ™ |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants in the Philippines who received ROTATEQ.™ Information will be provided by the physicians who administered the vaccine.
Key inclusion criteria (1 listed)
- Received ROTATEQ™
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with adverse events following administration of ROTATEQ™
Time frame: Three-year period following vaccine marketing approval (August 2007 to August 2010)
Results and safety
The study was stopped early (reason given: Merck Sharp \& Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotavirus Infections and Gastroenteritis, run by Merck Sharp & Dohme LLC.
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 0 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: stopped early, as of the sponsor's last update on 30 Oct 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 was stopped early (reason given: Merck Sharp \& Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study). Results are not available in the source record.
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?
Number of participants with adverse events following administration of ROTATEQ™ (time frame: Three-year period following vaccine marketing approval (August 2007 to August 2010)). 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 Oct 2015.