Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)
- Conditions
- Human Papillomavirus Infection
- Registration Number
- NCT01078220
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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™.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 189629
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™
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence Rate of Syncope On day of each vaccination 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.
Incidence Rate of Cellulitis Within 14 days and within 60 days immediately after each vaccination 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.
- Secondary Outcome Measures
Name Time Method Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy First dose of Gardasil in pregnancy up to 6 months after birth Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.
Number of Miscarriages Among Females Who Received Gardasil During Pregnancy First dose of Gardasil in pregnancy up to pregnancy resolution Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.
Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil within 6 months immediately after each vaccination 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.