Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26- Year-Old Women
Brief Summary: The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503 reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type 6/11/16/18 antibodies compared with GARDASIL.


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: Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group (At the time of Visit 5 (i.e. at 18.5 years of age))
C: Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis) (From Day 1 until >=30 cases accumulate, up to Month 54 in the base study); Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (End-of-study Update) (Up to Month 54 in the base study); Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58 (4 weeks postdose 3 in the base study); Base Study: Percentage of Participants With One or More Adverse Event (Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)); Base Study: Percentage of Participants With One or More Injection-site Adverse Event (Up to Day 5 after any vaccination); Base Study: Percentage of Participants With One or More Non-injection-site (Systemic) Adverse Event (Up to Day 15 after any vaccination); Base Study: Percentage of Participants With One or More Vaccine-related Adverse Event (Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)); Base Study: Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event (Up to Month 6)
D: Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) (4 weeks post-vaccination 3 (Month 7)); Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) (4 weeks post-vaccination 3 (Month 7)); Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) (4 weeks post-vaccination 3 (Month 7)); Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs) (Up to 5 days after any vaccination); Base Study: Percentage of Participants With Systemic AEs (Up to 15 days after any vaccination); Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) (Up to 5 days after any vaccination); Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine (Up to ~Month 126); Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine (Up to ~Month 126)

Answer: C