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

Human Papillomavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078220
• Other study ID #: V501-031
• Secondary ID: 2010_019EP08014.
• Status: Completed
• Phase: N/A
• First received: February 26, 2010
• Last updated: July 21, 2015
• Start date: February 2007
• Est. completion date: December 2010

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189629
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Kaiser Permanente

References & Publications (2)

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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes