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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

189629 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-06

Study Completion Date

2010-12-13

Brief Summary

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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™.

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Detailed Description

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Conditions

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Human Papillomavirus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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3-Dose Safety Population (Primary)

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.

No interventions assigned to this group

Pregnancy Safety Population

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

No interventions assigned to this group

Autoimmune Safety Population

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.

No interventions assigned to this group

Any Dose Safety Population (Secondary)

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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

9 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes