Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.
Brief Summary: Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes 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. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 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 2 dose Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix, Drug: Placebo | Arm Label: Gardasil 2 dose Group; Type: EXPERIMENTAL; Interventions: Biological: Gardasil, Drug: Placebo | Arm Label: Gardasil 3 dose Group; Type: EXPERIMENTAL; Interventions: Biological: Gardasil | Intervention Type: BIOLOGICAL; Name: Cervarix; Assigned to Arm(s): Cervarix 2 dose Group | Intervention Type: BIOLOGICAL; Name: Gardasil; Assigned to Arm(s): Gardasil 2 dose Group, Gardasil 3 dose Group | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cervarix 2 dose Group, Gardasil 2 dose Group
B: Arm Label: 0,2,6 month vaccination schedule; Type: ACTIVE_COMPARATOR; Interventions: Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine | Arm Label: 0,3,9 month vaccination schedule; Type: ACTIVE_COMPARATOR; Interventions: Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine | Arm Label: 0,6,12 month vaccination schedule; Type: ACTIVE_COMPARATOR; Interventions: Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine | Arm Label: 0,12,24 month vaccination schedule; Type: ACTIVE_COMPARATOR; Interventions: Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine | Intervention Type: BIOLOGICAL; Name: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine; Assigned to Arm(s): 0,12,24 month vaccination schedule, 0,2,6 month vaccination schedule, 0,3,9 month vaccination schedule, 0,6,12 month vaccination schedule
C: Arm Label: Cervarix Group; Type: EXPERIMENTAL; Interventions: Biological: HPV GSK 580299 vaccine | Arm Label: Placebo Group; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo control | Intervention Type: BIOLOGICAL; Name: HPV GSK 580299 vaccine; Assigned to Arm(s): Cervarix Group | Intervention Type: BIOLOGICAL; Name: Placebo control; Assigned to Arm(s): Placebo Group
D: Arm Label: Cervarix Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix™ | Arm Label: Havrix Group; Type: ACTIVE_COMPARATOR; Interventions: Biological: Havrix™-based investigational formulation | Intervention Type: BIOLOGICAL; Name: Cervarix™; Assigned to Arm(s): Cervarix Group | Intervention Type: BIOLOGICAL; Name: Havrix™-based investigational formulation; Assigned to Arm(s): Havrix Group

Answer: D