A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women
16 Years
26 Years
Both
Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia
Trial Information
A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women
Study participants will be administered a 3-dose regimen of V503. They will be assessed for
immunogenicity 1 month following completion of vaccination. All participants will be
followed for safety for a total of 12 months.
Inclusion Criteria:
- Good physical health
- Has never had Pap testing (cervical or anal) or has only had normal Pap test results
- Other inclusion criteria will be discussed with the investigator
Exclusion Criteria:
- History of severe allergic reaction that required medical intervention
- Currently enrolled in a clinical trial
- If participant is female, pregnant
- Currently immunocompromised or having received immunosuppressive therapy in the last
year
- Positive test for HPV
- History of HPV-related external genital lesions or HPV-related anal lesions or anal
cancer
- If participant is female, history of abnormal cervical biopsy results
- Other exclusion criteria will be discussed with the investigator
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Geometric mean titers (GMTs) to the HPV types contained in the V503 vaccine
Outcome Time Frame:
Four weeks post vaccination 3
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
V503-003
NCT ID:
NCT01651949
Start Date:
October 2012
Completion Date:
August 2014
Related Keywords:
- Genital Warts
- Anal Cancer
- Anal Intraepithelial Neoplasia
- Anus Neoplasms
- Neoplasms
- Condylomata Acuminata
- Carcinoma in Situ
Name | Location |
|---|---|
| Call for Information (Investigational Site 0255) | Houston, Texas 77055 |
| Call for Information (Investigational Site 0238) | Alhambra, California 91801 |
| Call for Information (Investigational Site 0263) | San Francisco, California 94115 |
| Call for Information (Investigational Site 0237) | Spring Valley, California 91978 |
| Call for Information (Investigational Site 0250) | Coral Gables, Florida 33134 |
| Call for Information (Investigational Site 0248) | Miami, Florida 33135 |
| Call for Information (Investigational Site 0247) | South Miami, Florida 33143 |
| Call for Information (Investigational Site 0026) | Tampa, Florida 33617 |
| Call for Information (Investigational Site 0230) | Chicago, Illinois 60612 |
| Call for Information (Investigational Site 0233) | Indianapolis, Indiana 46202 |
| Call for Information (Investigational Site 0249) | Marrero, Louisiana 70072 |
| Call for Information (Investigational Site 0242) | Elkridge, Maryland 21075 |
| Call for Information (Investigational Site 0229) | Kansas City, Missouri 64114 |
| Call for Information (Investigational Site 0264) | New York, New York 10011 |
| Call for Information (Investigational Site 0241) | Rochester, New York 14609 |
| Call for Information (Investigational Site 0231) | Cincinnati, Ohio 45227 |
| Call for Information (Investigational Site 0025) | Philadelphia, Pennsylvania 19107 |
| Call for Information (Investigational Site 0240) | Philadelphia, Pennsylvania 19114 |
| Call for Information (Investigational Site 0244) | Providence, Rhode Island 02906 |
| Call for Information (Investigational Site 0232) | Nashville, Tennessee 37203 |
| Call for Information (Investigational Site 0235) | Salt Lake City, Utah 84121 |
| Call for Information (Investigational Site 0245) | Richmond, Virginia 23233 |
