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Completed

NCT Number: NCT01078220

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

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™.

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Key information

Conditions

Human Papillomavirus Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

9 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence Rate of Syncope

    Time frame: On day of each vaccination

    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.

  2. Incidence Rate of Cellulitis

    Time frame: Within 14 days and within 60 days immediately after each vaccination

    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 outcomes

  1. 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

    Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.

  2. Number of Miscarriages Among Females Who Received Gardasil During Pregnancy

    Time frame: First dose of Gardasil in pregnancy up to pregnancy resolution

    Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Kaiser Permanente

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 2, 2010
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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