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NCT01355003 Clinical Trial

GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)

Papillomavirus Infections Clinical Trial

Official title:
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) Post Marketing Surveillance Protocol

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01355003
Other study ID # V501-077
Secondary ID
Status Terminated
Phase N/A
First received May 16, 2011
Last updated August 11, 2015
Start date February 2008
Est. completion date June 2010

Study information
Verified date August 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 safety information on the use of GARDASIL™ in the Philippines.

Recruitment information / eligibility
Status Terminated
Enrollment 1080
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Years to 46 Years
Eligibility Inclusion Criteria:

- Received GARDASIL™

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

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 any dose of vaccine At least 30 days following any vaccine dose Yes
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