Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-up Study to Evaluate the Long-term Efficacy of a HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy, safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in the primary \& follow-up study will be enrolled in this long-term follow-up study. Subjects were aged 15-25 years at the time of entry into the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: 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)
B: Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 (Up to year 8); Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 (Up to year 9); Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18 (Up to year 7)
C: Median Florescent Intensities (MFI) of the Total Antibodies to Vaccine-included HPV Types (16/18/6/11) at Different Time Points (Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48); Frequency of Persistent HPV 16/18/6/11 Infection. (From date of marriage through to 7 years of follow-up); Frequency of HPV 16/18-associated Precancerous Lesions and Cancer. (Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen)
D: HPV-6 Antibody Level (Geometric Mean Titer of HPV-6) (Week 28); HPV-11 Antibody Level (Geometric Mean Titer of HPV-11) (Week 28); HPV-16 Antibody Level (Geometric Mean Titer of HPV-16) (Week 28); HPV-18 Antibody Level (Geometric Mean Titer of HPV-18) (Week 28)

Answer: B