Cervical Cancer, Genital Warts, Human Papillomavirus Infection, Vaginal Cancer, Vulvar Cancer
Conditions
Brief summary
The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.
Interventions
BIOLOGICALV504
V504 0.5 ml injection in 3 dose regimen for 6 month treatment period.
BIOLOGICALComparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.
BIOLOGICALComparator: Placebo (unspecified)
V504 Placebo in 3 dose regimen for 6 month treatment period.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
* Females between 16- to 26-years-old * Has never had Pap testing or has only had normal Pap test results. * Lifetime history of 0 to 4 sexual partners
Exclusion criteria
* History of an abnormal cervical biopsy result * History of a positive test for HPV; History of external genital/vaginal warts * Currently a user of illegal drugs or an alcohol abuser * History of severe allergic reaction that required medical attention * Are pregnant * Received a marketed HPV vaccine * Currently enrolled in a 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 |
|---|---|
| Geometric mean titers (GMTs) to HPV types contained in the administered vaccines | 4 weeks post dose 3 |
Secondary
| Measure | Time frame |
|---|---|
| Seroconversion percentages to HPV types contained in the administered vaccines | 4 weeks post dose 3 |
Outcome results
None listed