Healthy women aged 18-26 MedDRA version: 9.1 Level: LLT Classification code 10065136 Term: Human papilloma virus exposure
Conditions
Interventions
Trade Name: Gardasil
Product Name: Gardasil
Pharmaceutical Form: Solution for injection
Sponsors
Medizinische Universität Wien, Univ.Klinik für Dermatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female, healthy participants; age 18-26; no history of genital warts, abnormal Pap smears and anogenital dysplasia; fewer than 4 lifetime sexual partners Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous or current HPV infection; chronic disease; immunosuppression; hematologic disease; mental disorder; pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the human papillomavirus (HPV)-specific antibody status in oral fluids of individuals vaccinated with the quadrivalent HPV vaccine Gardasil;Secondary Objective: Correlation of antibody status in oral fluids with serum levels ;Primary end point(s): antibody status in serum and oral fluid after vaccination | — |
Countries
Austria
Outcome results
None listed