Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase II Study to Assess the Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Japanese Female Subjects Aged 20 - 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. This study will evaluate the efficacy in prevention of persistent HPV-16 or HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 - 25 years of age at study start. Approximately 1000 study subjects will either receive the HPV vaccine or a control vaccine (Hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.

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


Options:
A: Arm Label: Cervarix Group; Type: EXPERIMENTAL; Interventions: Biological: GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM), Biological: Placebo | Arm Label: Gardasil Group; Type: ACTIVE_COMPARATOR; Interventions: Biological: Gardasil ® (Merck & Co. Inc), Biological: Placebo | Intervention Type: BIOLOGICAL; Name: GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM); Assigned to Arm(s): Cervarix Group | Intervention Type: BIOLOGICAL; Name: Gardasil ® (Merck & Co. Inc); Assigned to Arm(s): Gardasil Group | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Gardasil Group | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Cervarix Group
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Biological: V504, Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Biological: Comparator: Placebo (unspecified) | Intervention Type: BIOLOGICAL; Name: V504; Assigned to Arm(s): 1 | Intervention Type: BIOLOGICAL; Name: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine; Assigned to Arm(s): 1, 2 | Intervention Type: BIOLOGICAL; Name: Comparator: Placebo (unspecified); Assigned to Arm(s): 2
C: Arm Label: Cervarix Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix vaccine | Arm Label: Engerix-B Group; Type: ACTIVE_COMPARATOR; Interventions: Biological: Engerix-B vaccine | Intervention Type: BIOLOGICAL; Name: Cervarix vaccine; Assigned to Arm(s): Cervarix Group | Intervention Type: BIOLOGICAL; Name: Engerix-B vaccine; Assigned to Arm(s): Engerix-B Group
D: Arm Label: Cervarix Group; Type: EXPERIMENTAL; Interventions: Biological: HPV-16/18 vaccine (Cervarix™) | Arm Label: Aimmugen Group; Type: ACTIVE_COMPARATOR; Interventions: Biological: Aimmugen™ | Intervention Type: BIOLOGICAL; Name: HPV-16/18 vaccine (Cervarix™); Assigned to Arm(s): Cervarix Group | Intervention Type: BIOLOGICAL; Name: Aimmugen™; Assigned to Arm(s): Aimmugen Group

Answer: D