Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil)(V501-015 AM5; EXT1; EXT2(AM1))

• Tolerability; Incidence of the Composite Endpoint of HPV 16 or HPV 18 Related CIN2/3 or Invasive Cervical Carcinoma After Completion of the Vaccination Series for Relevant HPV Type [ Time Frame: Follow-up through end of study (4 years) ] [ Designated as safety issue: No ]

  Tolerability = Number of subjected affected. Incidence Rate per person-years of follow-up.

  The tolerability objective was to demonstrate that Gardasil is generally well tolerated by females aged 16-23. The relevant data are presented in the Reported Adverse Events section. No formal statistical hypothesis testing were performed for this objective.

  
  

• Subjects With Anti-HPV 6 Titer >/= 20 mMU/mL [ Time Frame: week 4 Postdose 3 (4 weeks after 3rd vaccine dose) ] [ Designated as safety issue: No ]
  Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20 mMU/mL
  
  
• Subjects With Anti-HPV 11 Titer >/= 16 mMU/mL [ Time Frame: week 4 Postdose 3 ] [ Designated as safety issue: No ]
  Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 16 mMU/mL
  
  
• Subjects With Anti-HPV 16 Titer >/= 20 mMU/mL [ Time Frame: week 4 Postdose 3 ] [ Designated as safety issue: No ]
  Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20mMU/mL
  
  
• Subjects With Anti-HPV 18 Titer >/= 24 mMU/mL [ Time Frame: week 4 Postdose 3 ] [ Designated as safety issue: No ]
  Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 24 mMU/mL
  
  

The original base study (V501-015) (NCT00092534) was extended in protocol V501-015-10. Subjects in the placebo arm of the base study were given 3 doses of open-label GARDASIL™ (V501) at Extension (EXT) Day 1, EXT Month 2 and EXT Month 6 and were followed to EXT Month 7. Subjects who received only 1 dose of GARDASIL™ in the base study were given 3 doses of open-label GARDASIL™ (V501) at Extension (EXT) Day 1, EXT Month 2 and EXT Month 6 and were followed to EXT Month 7. Subjects who received 2 doses of GARDASIL™ in the base study were given only 1 dose of GARDASIL™ at EXT Day 1 and were followed for 15 days (day of vaccination plus 14 days).

A second extension study, V501-015-20, will assess the effectiveness, immunogenicity and safety of GARDASIL™ during a period of 10-14 years following completion of the base study (V501-015) or the V501-015-10 extension. Subjects from Denmark, Iceland, Norway and Sweden who participated in the base study were eligible to enroll. Effectiveness and safety will be assessed by registry-based follow-up. Immunogenicity will be assessed by serological testing at approximately Year 5 and Year 10 of the V501-015-20 extension, respectively.