N/A
Completed N=189,629
Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)
Source: ClinicalTrials.gov NCT01078220 ↗Enrolled (actual)
189,629
Serious AEs
—
Results posted
Jan 2012
Primary outcomePrimary: Incidence Rate of Syncope — 24.21; 13.84 Rate per 1000 person years
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™.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Syncope |
24.21; 13.84 | — |
| PRIMARY Incidence Rate of Cellulitis |
3.53; 2.17; 2.25; 1.66 | — |
| SECONDARY Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy |
170; 170; 44; 0 | — |
| SECONDARY Number of Miscarriages Among Females Who Received Gardasil During Pregnancy |
633; 100; 9; 0 | — |
| SECONDARY Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil |
719; 318; 124; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01078220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.