Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica.
Brief Summary: RATIONALE: Chemoprevention is the use of certain drugs to keep cancer form forming, growing, or coming back. Vaccines may help the body build an effective immune response against human papillomavirus and may be effective in preventing cervical intraepithelial neoplasia or cervical cancer. It is not yet known whether human papillomavirus vaccine is more effective than hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer.

PURPOSE: This randomized phase III trial is studying human papillomavirus vaccine to see how well it works compared to hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer in younger healthy participants.


Options:
A: Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen. (From Month 6 up to Month 48)
B: Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 (Up to Month 18); Number of Participants Reporting SAEs From Month 18 Through Month 37 (Month 18 to Month 37); Number of Participants Reporting Other (Non-serious) AEs Through Month 18 (Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination); Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 (Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)); Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 (Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)); Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 (Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)); Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 (Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)); Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 (Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)); Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 (Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)); Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up (Month 37 to Month 126)
C: Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (At 18, 24, 36 and 48 months)
D: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 (At Month 7); Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) (At Month 7)

Answer: A