Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study
Brief Summary: This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease in mid-adult women.


Options:
A: Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7 (At Month 7); Number of Seroconverted Subjects for Anti-HPV-18 at Month 7 (At Month 7); Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7 (At Month 7); Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7 (At Month 7)
B: Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
C: Immunogenicity After Dose 3 (1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months))
D: Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer (Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study); Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study (Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)); Number of Participants With Vaccine-Related SAEs After Vaccine Administration (qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120); Number of Participants With an SAE Resulting in Death After Vaccine Administration (qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120); Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4 (Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)); Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8 (From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study); Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10 (From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study); Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4 (Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)); Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8 (From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study); Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10 (From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study (Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study (Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study (Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study (Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study (Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study (Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study (Month 96 (90 months after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study (Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study (Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study (Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study (Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study (Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study (Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study (Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study (Month 96 (96 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study (Month 120 (114 months after the third dose of qHPV vaccine in the Base Study))

Answer: D