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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Human Papillomavirus Infection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01078220

EP08014.031 (Other Identifier)

V501-031

2010_019

Details and patient eligibility

About

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™.

Enrollment: 189,629 patients

Sex: Female

Ages: 9+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

189,629 participants in 4 patient groups

3-Dose Safety Population (Primary)

Description:

Females between ages 9 to 26 at receipt of the first dose of GARDASIL who are members of the participating MCOs and have completed the 3-dose regimen of GARDSIL vaccination with 12 months.

Pregnancy Safety Population

Description:

Females who received at least one dose of GARDASIL during pregnancy.

Autoimmune Safety Population

Description:

Females who have received at least one dose of GARDASIL and have been members in the same MCO for at least 12 months prior to receiving their first dose of GARDASIL.

Any Dose Safety Population (Secondary)

Description:

Females who have received at least one dose of GARDASIL and have been members in the same MCO for at least 12 months prior to receiving their first dose of GARDASIL.