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NCT01357174 Clinical Trial

ROTATEQ™ Post-Marketing Surveillance in the Philippines

Gastroenteritis Clinical Trial

Official title:
Protocol for ROTATEQ™ Post-Marketing Surveillance

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01357174
Other study ID # V260-046
Secondary ID
Status Terminated
Phase N/A
First received May 18, 2011
Last updated October 29, 2015
Start date October 2007
Est. completion date September 2010

Study information
Verified date October 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Philippines: Bureau of Food and Drugs
Study type Observational

Clinical Trial Summary

This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.

Recruitment information / eligibility
Status Terminated
Enrollment 915
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Weeks to 12 Weeks
Eligibility Inclusion Criteria:

- Received ROTATEQ™

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events following administration of ROTATEQ™ Three-year period following vaccine marketing approval (August 2007 to August 2010) Yes
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