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)
Verified date | March 2017 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
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
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Primary | Tolerability and immune responses at week 4 post dose 3. |
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