Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Evaluate Safety, Immunogenicity and Efficacy of GSK Biologicals HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a Three-dose Schedule (0, 1, 6 Month) in Healthy Adult Female Subjects Aged 26 Years and Above
Brief Summary: This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study participation will last approximately 48 months and involves a total of eleven scheduled visits. Under Protocol Amendment 4, study participation will last up to 84 months and involves a maximum of seventeen scheduled visits.


Options:
A: Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. (Up to Month 48); Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). (Up to Month 48); Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. (Up to Month 84); Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). (Up to Month 84)
B: Incidence of Persistent HPV 16 Infection (Through Month 48); Incidence of HPV 16-related CIN1, CIN2 or C1N3 (Through Month 48); Serum Anti-HPV 16 Geometric Mean Titers (Month 7)
C: 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)
D: Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms (Within 7 days after each vaccine dose)

Answer: A