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


N/A
9 Years
N/A
Not Enrolling
Female
Human Papillomavirus Infection

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Incidence Rate of Syncope

Outcome Description:

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.

Outcome Time Frame:

On day of each vaccination

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Institutional Review Board

Study ID:

V501-031

NCT ID:

NCT01078220

Start Date:

February 2007

Completion Date:

December 2010

Related Keywords:

  • Human Papillomavirus Infection
  • Human Papillomavirus (HPV)
  • Warts
  • Papillomavirus Infections

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