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
• 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

• Papillomavirus Infections

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