Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
Brief Summary: This was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).


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 HR-HPV infections and number of infections due to HPV vaccine types in cervical sample in the Experimental arm and in No intervention arm (30 months); number of cytological abnormalities in the Experimental arm and in No intervention arm (30 months)
C: 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))
D: Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45 (18 months from enrollment)

Answer: C