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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


Phase 3
16 Years
26 Years
Open (Enrolling)
Both
Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia

Thank you

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