Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

Cervical Cancer Clinical Trial

Official title:

Immunogenicity and Safety of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Consistency Lots for 16- to 23-Year-Old Women With and Additional Immunogenicity Bridge to the Monovalent HPV 16 Vaccine Pilot Manufacturing Lot Study-The F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092482
• Other study ID #: V501-012
• Secondary ID: 2004_080
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2004
• Last updated: March 20, 2017
• Start date: June 28, 2002
• Est. completion date: August 15, 2008

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3882
• Est. completion date: August 15, 2008
• Est. primary completion date: June 30, 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 23 Years

Eligibility

Inclusion Criteria:

• Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

• Prior Human Papillomavirus Vaccine (HPV) vaccination;

• Prior abnormal paps;

• Prior history of genital warts

Related Conditions & MeSH terms

• Cervical Cancer
• Condylomata Acuminata
• Genital Warts
• Uterine Cervical Neoplasms

Intervention

Biological:
• V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (3)

Brown DR, Garland SM, Ferris DG, Joura E, Steben M, James M, Radley D, Vuocolo S, Garner EI, Haupt RM, Bryan JT. The humoral response to Gardasil over four years as defined by total IgG and competitive Luminex immunoassay. Hum Vaccin. 2011 Feb;7(2):230-8. — View Citation

Garland SM, Steben M, Hernandez-Avila M, Koutsky LA, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GW, Ferris DG, Esser MT, Vuocolo SC, Nelson M, Railkar R, Sattler C, Barr E; 012 Study Investigators.. Noninferiority of antibody response to human papillomavirus type 16 in subjects vaccinated with monovalent and quadrivalent L1 virus-like particle vaccines. Clin Vaccine Immunol. 2007 Jun;14(6):792-5. — View Citation

Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability and immune responses at week 4 post dose 3.