Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003 AM5)

Status:	Completed
Conditions:	Colorectal Cancer, Colorectal Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	16 - 26
Updated:	7/16/2013
Start Date:	October 2012
End Date:	August 2014
Contact:	Toll Free Number
Phone:	1-888-577-8839

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

This study is designed to evaluate the immunogenicity and tolerability of V503 in 16- to
26-year old men and women. The overall goal is to bridge V503 efficacy findings in young
women to young men based on the demonstration of similar immunogenicity and safety profiles.

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

We found this trial at

sites

Clinical Trial Facility in Coral Gables Florida

Coral Gables, Florida 33134

from

Coral Gables, FL