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

NCT01078220 | Completed Results DMC

• 3 other identifiers: V501-0312010_019EP08014.031
• Study Type: observational
• Target: 189,629
• Locations: 0 countries
• Sites: N/A

Brief 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™.

Conditions

Human Papillomavirus Infection

Keywords

Human Papillomavirus (HPV)

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy

  First dose of Gardasil in pregnancy up to 6 months after birth

• Number of Miscarriages Among Females Who Received Gardasil During Pregnancy

  First dose of Gardasil in pregnancy up to pregnancy resolution

• Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil

  within 6 months immediately after each vaccination

Study Arms (4)

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 Criteria

• Age: 9 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Managed Care Organizations (MCO) databases

You may qualify if:

• 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™

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Kaiser Permanente: collaborator

Related 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 Med. 2012 Feb;271(2):193-203. doi: 10.1111/j.1365-2796.2011.02467.x. Epub 2011 Nov 15.

  PMID: 21973261 RESULT

• 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 Med. 2012 Dec;166(12):1140-8. doi: 10.1001/archpediatrics.2012.1451.

  PMID: 23027469 RESULT

Related Links

• EUPAS Register (EUPAS17730)

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 2, 2010
• Study Start: February 6, 2007
• Primary Completion: December 13, 2010
• Study Completion: December 13, 2010
• Last Updated: July 11, 2017
• Results First Posted: January 9, 2012

Record last verified: 2017-06