V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)

A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women

This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.

Inclusion Criteria:

• Healthy Japanese females
• Not pregnant at Screening and agree to use effective contraception through Month 7 of the study
• Lifetime history of 0 to 4 male or female sexual partners
• No oral temperature ≥37.5 centigrade within 24 hours prior to injection

Exclusion Criteria:

• Received a marketed HPV vaccine
• Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN
• Known history of positive test for HPV
• Known history of genital warts
• Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study
• History of splenectomy, known immune disorders, or receiving immunosuppressives
• Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)