Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine (GSK1674330A) in Healthy Female Subjects Aged 18-25 Years.
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. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals' HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control vaccine. There will be different levels of blinding in the study.

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


Options:
A: Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer (Base study: through Month 36); Overall Study: Incidence of HPV Type 6/11-related Genital Warts (Up to 10 years after the first dose of qHPV vaccine); Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer (Up to 10 years after the first dose of qHPV vaccine); Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer (Up to 10 years after the first dose of qHPV vaccine); Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs) (Base study: through Day 5 after any vaccination); Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) (Base study: through Month 36); LTFU (EXT2): Number of Participants With Vaccine-Related SAEs (LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine); LTFU (EXT2): Number of Participants Who Died (LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine)
B: Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms (Within 7 days after each vaccine dose)
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: Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies (One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).); Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms (Within 7 days (Day 0-6) after vaccination.); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (Within 7 days (Day 0-6) after vaccination.)

Answer: B