9vHPV vaccine is indicated in females ≥ 9 years of age in the prevention of cervical, vulvar, vaginal, and anal cancer; precancerous or dysplastic lesions; and persistent infections caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58, and genital warts (condyloma acuminata) caused by HPV types 6 and 11.
Conditions
Brief summary
Combined Incidence of Human Papillomavirus (HPV) Type 16, 18, 31, 33, 45, 52, or 58-related CIN Grades 2 or 3, Adenocarcinoma in Situ (AIS), and Cervical Cancer in Cohort 1
Detailed description
Combined Incidence of CIN 2, CIN 3, AIS, or cervical cancer related to HPV 35, 39, 51, 56, or 59, Combined Incidence of CIN (any grade), AIS, cervical cancer, vulvar cancer, or vaginal cancer related to HPV 6, 11, 16, 18, 31, 33, 45, 52, or 58, Geometric Mean Titers (GMTs) of HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58, Seropositivity rates of HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58
Interventions
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined Incidence of Human Papillomavirus (HPV) Type 16, 18, 31, 33, 45, 52, or 58-related CIN Grades 2 or 3, Adenocarcinoma in Situ (AIS), and Cervical Cancer in Cohort 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Combined Incidence of CIN 2, CIN 3, AIS, or cervical cancer related to HPV 35, 39, 51, 56, or 59, Combined Incidence of CIN (any grade), AIS, cervical cancer, vulvar cancer, or vaginal cancer related to HPV 6, 11, 16, 18, 31, 33, 45, 52, or 58, Geometric Mean Titers (GMTs) of HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58, Seropositivity rates of HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 | — |
Countries
Denmark, Norway, Sweden
Outcome results
None listed