A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Women's Studies, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 9 - 26 |
| Updated: | 5/5/2014 |
| Start Date: | December 2013 |
| End Date: | August 2017 |
| Contact: | Toll Free Number |
| Phone: | 1-888-577-8839 |
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 (16 to 26 Year Olds)
This study is a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14
years of age and in females 16 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) studied in boys and
girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response
that is not inferior to that observed in females 16 to 26 years of age (the core efficacy
population, assessed concurrently in this study) who received the standard 3-dose regimen of
V503.
years of age and in females 16 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) studied in boys and
girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response
that is not inferior to that observed in females 16 to 26 years of age (the core efficacy
population, assessed concurrently in this study) who received the standard 3-dose regimen of
V503.
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
We found this trial at
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