Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Long-term Extension Study of the Efficacy of the 580299 Vaccine in the Prevention of HPV-16 and/or HPV-18 Associated Cervical Intraepithelial Neoplasia (CIN) in Japanese Women Vaccinated in the Primary Vaccination Study NCT00316693
Brief Summary: This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic HPV types for an additional two years. All subjects who participated in the primary vaccination study NCT00316693 and who confirmed their interest in participating in a long term follow up study will therefore be invited to be followed for up to 48 months after administration of the first dose of vaccine. In addition, safety and persistence of the humoral immune response will be evaluated in this study.

This protocol posting deals with objectives \& outcome measures of the extension phase at Months 36 and 48. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00316693).


Options:
A: Arm Label: Cervarix Group; Type: EXPERIMENTAL; Interventions: Procedure: Liquid-based cytology (LBC) sampling, Procedure: Blood sampling | Arm Label: Aimmugen Group; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Liquid-based cytology (LBC) sampling | Intervention Type: PROCEDURE; Name: Liquid-based cytology (LBC) sampling; Assigned to Arm(s): Aimmugen Group, Cervarix Group | Intervention Type: PROCEDURE; Name: Blood sampling; Assigned to Arm(s): Cervarix Group
B: Arm Label: Cervarix™ & Engerix™ Group; Type: EXPERIMENTAL; Interventions: Biological: Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™), Biological: Engerix™ | Arm Label: Engerix™ Group; Type: ACTIVE_COMPARATOR; Interventions: Biological: Engerix™ | Intervention Type: BIOLOGICAL; Name: Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™); Assigned to Arm(s): Cervarix™ & Engerix™ Group | Intervention Type: BIOLOGICAL; Name: Engerix™; Assigned to Arm(s): Cervarix™ & Engerix™ Group, Engerix™ Group
C: Arm Label: qHPV Vaccine in Base Study; Type: EXPERIMENTAL; Interventions: Biological: V501 | Arm Label: Placebo in Base Study; Type: PLACEBO_COMPARATOR; Interventions: Biological: Comparator: Placebo | Arm Label: qHPV Vaccine in Extension Study; Type: EXPERIMENTAL; Interventions: Biological: V501 | Intervention Type: BIOLOGICAL; Name: V501; Assigned to Arm(s): qHPV Vaccine in Base Study, qHPV Vaccine in Extension Study | Intervention Type: BIOLOGICAL; Name: Comparator: Placebo; Assigned to Arm(s): Placebo in Base Study
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Biological: V501 | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Biological: Comparator: Placebo | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Biological: Human Papillomavirus (HPV) 16 Monovalent | Intervention Type: BIOLOGICAL; Name: V501; Assigned to Arm(s): 1 | Intervention Type: BIOLOGICAL; Name: Comparator: Placebo; Assigned to Arm(s): 2 | Intervention Type: BIOLOGICAL; Name: Human Papillomavirus (HPV) 16 Monovalent; Assigned to Arm(s): 3

Answer: A