Vaccine

Study: Merck V503-010

Status: Enrolling

In/Outpatient: Outpatient

Location:

Diablo Clinical Research

2255 Ygnacio Valley Road, Suite M

Walnut Creek, CA 94598

Principal Investigator

San Francisco Bay Area Clinical Trials

Helen Lee Stacey

Internist

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.

Summary:

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.

 

Physicians Note:

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:

Inclusion Criteria:

All Participants:

-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

Exclusion Criteria:

All Participants:

  • 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.