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

This study has been completed.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01078220
First received: February 26, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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™.


Condition
Human Papillomavirus Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence Rate of Syncope [ Time Frame: On day of each vaccination ] [ Designated as safety issue: Yes ]
    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.

  • Incidence Rate of Cellulitis [ Time Frame: Within 14 days and within 60 days immediately after each vaccination ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy [ Time Frame: First dose of Gardasil in pregnancy up to 6 months after birth ] [ Designated as safety issue: Yes ]
    Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.

  • Number of Miscarriages Among Females Who Received Gardasil During Pregnancy [ Time Frame: First dose of Gardasil in pregnancy up to pregnancy resolution ] [ Designated as safety issue: Yes ]
    Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.

  • Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil [ Time Frame: within 6 months immediately after each vaccination ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 189629
Study Start Date: February 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
3-Dose Safety Population (Primary)
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.
Pregnancy Safety Population
Females who received at least one dose of GARDASIL during pregnancy.
Autoimmune Safety Population
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.
Any Dose Safety Population (Secondary)
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.

  Eligibility

Ages Eligible for Study:   9 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Managed Care Organizations (MCO) databases

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078220

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Kaiser Permanente
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01078220     History of Changes
Other Study ID Numbers: V501-031, 2010_019, EP08014.031
Study First Received: February 26, 2010
Results First Received: November 23, 2011
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Merck Sharp & Dohme Corp.:
Human Papillomavirus (HPV)

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014