Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) Co-administered With Boostrix Polio (dTpa-IPV) in Healthy Female Subjects Aged 10-18 Years
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals' (580299)HPV-16/18 L1 AS04 vaccine (Cervarix TM) as compared to the administration of either vaccine alone.

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


Options:
A: Number of Subjects Seroprotected Against Diphtheria and Tetanus (One month after vaccination with Boostrix Polio); Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies (One month after vaccination with Boostrix Polio); Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3 (One month after vaccination with Boostrix Polio)
B: Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
C: Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 60); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 72); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 84); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 96); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 60); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At month 72); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 84); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 96); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 108); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 108); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 120); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 120)
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: A