ROTATEQ™ Post-Marketing Surveillance in the Philippines
October 29, 2015 updated by: Merck Sharp & Dohme LLC
Protocol for ROTATEQ™ Post-Marketing Surveillance
This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
915
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Infants in the Philippines who received ROTATEQ.™
Information will be provided by the physicians who administered the vaccine.
Description
Inclusion Criteria:
- Received ROTATEQ™
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
All Participants
Infants who were vaccinated with ROTATEQ™
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with adverse events following administration of ROTATEQ™
Time Frame: Three-year period following vaccine marketing approval (August 2007 to August 2010)
|
Three-year period following vaccine marketing approval (August 2007 to August 2010)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
May 18, 2011
First Submitted That Met QC Criteria
May 18, 2011
First Posted (Estimate)
May 20, 2011
Study Record Updates
Last Update Posted (Estimate)
October 30, 2015
Last Update Submitted That Met QC Criteria
October 29, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V260-046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.