GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)
This study has been terminated.
(Merck Sharp & Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study)
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01355003
First received: May 16, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
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Purpose
This study will collect safety information on the use of GARDASIL™ in the Philippines.
| Condition |
|---|
|
Papillomavirus Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) Post Marketing Surveillance Protocol |
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of participants with adverse events following any dose of vaccine [ Time Frame: At least 30 days following any vaccine dose ] [ Designated as safety issue: Yes ]
| Enrollment: | 1080 |
| Study Start Date: | February 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
All Participants
Participants who were vaccinated with GARDASIL™ by their physician
|
Eligibility| Ages Eligible for Study: | 9 Years to 46 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Data will be collected from physicians who prescribed GARDASIL™ and who voluntarily agree to provide information on their patients. Each physician can provide up to five reports corresponding to five patients.
Criteria
Inclusion Criteria:
- Received GARDASIL™
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT01355003 History of Changes |
| Other Study ID Numbers: | V501-077 |
| Study First Received: | May 16, 2011 |
| Last Updated: | May 16, 2011 |
| Health Authority: | Philippines: Bureau of Food and Drugs |
Additional relevant MeSH terms:
|
Papillomavirus Infections DNA Virus Infections Virus Diseases Tumor Virus Infections |
ClinicalTrials.gov processed this record on June 13, 2013