Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)

A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting

This is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used GARDASIL™.

Inclusion Criteria:

3-Dose Safety Population

• Female 9-26 years at the time of first dose of GARDASIL™
• Completed the 3-dose regimen of GARDASIL™ per protocol

Pregnancy Safety Population

• Received at least one dose of GARDASIL™ up to 30 days prior to the date of conception or any time between conception and the day of pregnancy resolution

Autoimmune Safety Population

• Female who has received at least one dose of GARDASIL™
• Has been a member of same Managed Care Organization (MCO) for at least 12 months prior to the receipt of GARDASIL™

Any Dose Safety Population

• Female who has received at least one dose of GARDASIL™

Exclusion Criteria:

3-Dose Safety Population

• Male
• Receives incomplete regimen of GARDASIL™
• Completes the three dose regimen of GARDASIL™ in more than 12 months
• Less than 28 day interval between doses 1 and 2 or less than a 12 week interval between doses 2 and 3
• Younger than 9 or older than 26 years of age at receipt of first dose

Pregnancy Safety Population

• Males
• No record of pregnancy at the Managed Care Organization (MCO)

Autoimmune Safety Population

• Member of the same MCO for less than 12 months prior to receiving the first dose
• Male