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