Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Open, Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start. Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule. The study will be extended to assess long-term safety and immunogenicity of the HPV-16/18 vaccine.


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 Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age (At Month 7); Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48 (At Months 18, 24, 36 and 48)
C: Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer (Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study); Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study (Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)); Number of Participants With Vaccine-Related SAEs After Vaccine Administration (qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120); Number of Participants With an SAE Resulting in Death After Vaccine Administration (qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120); Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4 (Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)); Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8 (From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study); Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10 (From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study); Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4 (Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)); Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8 (From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study); Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10 (From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study (Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study (Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study (Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study (Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study (Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study (Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study (Month 96 (90 months after the third dose of qHPV vaccine in the Base Study)); Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study (Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study (Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study (Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study (Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study (Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study (Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study (Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study (Month 96 (96 months after the third dose of qHPV vaccine in the Base Study)); Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study (Month 120 (114 months after the third dose of qHPV vaccine in the Base Study))
D: 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)

Answer: B