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-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity (At Month 7 (i.e. one month after the last dose of study vaccine)); Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity (At Month 7 (i.e. one month after the last dose of study vaccine)); Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC) (At Month 7 (i.e. one month after the last dose of study vaccine))
B: Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) (Within 14 days of first three doses of vaccination); Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment (Within 14 days of first three doses of vaccination); Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion (At week 28 after beginning the vaccination series); Serum Anti-HPV Antibody Titers (cLIA) (Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124.)
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: Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))

Answer: C