Clinical trial · Observational
Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)
A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting
NCT01078220CI-TRIAL-00028565completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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™.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- 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.
- label
- Pregnancy Safety Population
- description
- Females who received at least one dose of GARDASIL during pregnancy.
- label
- 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.
- label
- 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.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 9 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTChao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, Ackerson B, Cheetham TC, Hansen J, Deosaransingh K, Emery M, Liaw KL, Jacobsen SJ. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012 Feb;271(2):193-203. doi: 10.1111/j.1365-2796.2011.02467.x. Epub 2011 Nov 15. PMID 21973261
- RESULTKlein NP, Hansen J, Chao C, Velicer C, Emery M, Slezak J, Lewis N, Deosaransingh K, Sy L, Ackerson B, Cheetham TC, Liaw KL, Takhar H, Jacobsen SJ. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1140-8. doi: 10.1001/archpediatrics.2012.1451. PMID 23027469