Cervical Cancer, Condylomata Acuminata
Conditions
Keywords
anogenital warts, premalignancy, HPV, Human papillomavirus
Brief summary
This study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by the HPV types in the study vaccine, (2) To demonstrate that the vaccine is well-tolerated in women, (3) To evaluate vaccine immune responses in women. This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).
Interventions
BIOLOGICALV502
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
* Female, between the ages of 16 and 26
Exclusion criteria
* History of an abnormal PAP test or abnormal cervical biopsy result * History of external genital/vaginal warts * History of positive HPV test * Currently a user of any illegal drugs or an alcohol abuser * Are pregnant * Currently enrolled in another clinical trial * Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proprietary Information - Exploratory (Non-Confirmatory) Trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Proprietary Information - Exploratory (Non-Confirmatory) Trial | — |
Outcome results
None listed