Study: Merck V503-010
Diablo Clinical Research
2255 Ygnacio Valley Road, Suite M
Walnut Creek, CA 94598
Helen Lee Stacey
Dr. Stacey, a Sub-Investigator with Diablo Clinical Research since 2000,
is an Internist with a Masters of Public Health. Before joining Diablo Clinical
Research, she had a general internal medicine practice with Muir Primary Care,
associated with the John Muir Medical Center.
This study is a 37-month safety and immunogenicity study conducted in females 18 to 26 years of age. From this study, the goal is to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) with an antibody response that is not inferior to that observed in females 18 to 26 years of age (the core efficacy population, assessed concurrently in this study) who received the standard 3-dose regimen of V503.
A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (18to 26 Year Olds)
Qualifications - Inclusions & Exclusions:
-Judged to be in good physical health on the basis of medical history, physical examination and laboratory results
Boys and Girls 9 to 14 Years:
-Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
Women 16 to 26 Years:
- Has never had a Pap test or only had normal Pap test results
- A lifetime history of 0 to 4 male and/or female sexual partners
- Known allergy to any vaccine component
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- Currently immunocompromised, or been diagnosed with immunodeficiency
- Had a splenectomy
- Receiving or has received immunosuppressive therapies within the last year
- Received any immunoglobulin product or blood-derived product within 3 months
- Received a marketed HPV vaccine or has participated in an HPV clinical trial
Compensation for Time and Travel:
Our patient volunteers receive all labs, physical exams, specialty exams
(mammograms, bone density tests, x-rays, etc) and specialty consults
(dietician, ophthalmologist, etc) free of charge. No insurance is required.
Volunteers are paid for their time and travel.