Clinical trial NCT01078220: Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)
Official title: A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Infection
Keywords: Human Papillomavirus (HPV)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
First posted: 2010-03-02
Enrollment: 189629
Sex: FEMALE
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Managed Care Organizations (MCO) databases

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™.


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

Primary outcomes:
measure: Incidence Rate of Syncope
timeFrame: On day of each vaccination
measure: Incidence Rate of Cellulitis
timeFrame: Within 14 days and within 60 days immediately after each vaccination
Secondary outcomes:
measure: Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy
timeFrame: First dose of Gardasil in pregnancy up to 6 months after birth
measure: Number of Miscarriages Among Females Who Received Gardasil During Pregnancy
timeFrame: First dose of Gardasil in pregnancy up to pregnancy resolution
measure: Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil
timeFrame: within 6 months immediately after each vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Chao 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.
citation: Klein 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.