Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

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.

Females who received at least one dose of GARDASIL during pregnancy.

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.

Medical Monitor

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™.

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

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

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.

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.

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

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.

Kaiser Permanente

Merck Sharp & Dohme LLC

Per protocol, non-serious adverse events and serious adverse events (SAEs)

were not required to be captured as part of the study database, therefore, none were collected, and the number at risk is zero.

Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.

Any Dose Safety Population

<9 years

Between 9 and 15 years

Between 16 and 26 years

>26 years

Age, Customized

Sex: Female, Male

Details of syncope and cellulitis findings and null findings for hundreds of other general safety analyses will be described in future publications.

Senior Vice President, Global Clinical Development

Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.

Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months

3-Dose Safety Population

Incidence Rate of Syncope

Number (No.) of potential congenital anomalies

No. that underwent medical record review

No. of confirmed congenital anomalies

No. associated with Gardasil by safety committee

Any female from the Any Dose Safety Population with suspected exposure to Gardasil during pregnancy.

Pregnancy Safety Population

Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.

Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy

No. of potential miscarriages indentified

No. of confirmed miscarriages

Number of Miscarriages Among Females Who Received Gardasil During Pregnancy

No. of potential autoimmune cases

No. of confirmed new onset cases within 6 months

Any female with at least 12 months of membership at a MCO prior to their first dose of Gardasil, in order to exclude pre-existing conditions prior to their first dose of Gardasil.

Autoimmune Safety Population

Number of females with at least 12 months' membership at a MCO prior to Gardasil.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial