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

Study Overview
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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™.

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

Conditions
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Human Papillomavirus Infection

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3-Dose Safety Population (Primary)<br>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<br>Females who received at least one dose of GARDASIL during pregnancy. | |
| Autoimmune Safety Population<br>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)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Syncope | Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a rule out diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study. | On day of each vaccination | 
| Incidence Rate of Cellulitis | Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a rule out diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study. | Within 14 days and within 60 days immediately after each vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy | Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy. | First dose of Gardasil in pregnancy up to 6 months after birth | 
| Number of Miscarriages Among Females Who Received Gardasil During Pregnancy | Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy. | First dose of Gardasil in pregnancy up to pregnancy resolution | 
| Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil | Autoimmune cases were defined as newly diagnosed cases within 6 months after any dose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest. | within 6 months immediately after each vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papillomavirus (HPV)