Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase IIIb, Observer-blind Study to Compare Immunogenicity of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Versus Gardasil® [Quadrivalent Human Papillomavirus (HPV-6,11,16,18 L1 VLP) Recombinant Vaccine Merck & Co., Inc.]
Brief Summary: HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in \> 70%, approximately, of all cervical cancers. Recently, Merck's HPV vaccine Gardasil® \[quadrivalent human papillomavirus (HPV-6,11,16,18 L1 VLP) recombinant vaccine\] has been approved by the FDA for prevention of genital tract cancers and pre-cancers and genital warts in females. Although the GSK HPV vaccine and Gardasil® have different compositions and are expected to have different efficacy profiles, each vaccine targets prevention of HPV-16 and 18 genital tract cancers and pre-cancers. Therefore, a comparison of the immunogenicity of the two vaccines is warranted. This Phase 3b study is designed to compare the immunogenicity of the GSK vaccine (HPV-16/18) to Gardasil® in healthy adult females 18-45 years of age.

The Protocol Posting has been updated as the study will be extended by 3 additional years.


Options:
A: Arm Label: Tetravalent Vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: Tetravalent Vaccine | Arm Label: Bivalent Vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: Bivalent Vaccines | Intervention Type: BIOLOGICAL; Name: Bivalent Vaccines; Assigned to Arm(s): Bivalent Vaccine | Intervention Type: BIOLOGICAL; Name: Tetravalent Vaccine; Assigned to Arm(s): Tetravalent Vaccine
B: 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
C: 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
D: Arm Label: Cervarix Group; Type: EXPERIMENTAL; Interventions: Biological: GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) | Arm Label: Boostrix Polio → Cervarix Group; Type: EXPERIMENTAL; Interventions: Biological: Boostrix ® Polio, Biological: GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) | Arm Label: Cervarix + Boostrix Polio Group; Type: EXPERIMENTAL; Interventions: Biological: Boostrix ® Polio, Biological: GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) | Intervention Type: BIOLOGICAL; Name: Boostrix ® Polio; Assigned to Arm(s): Boostrix Polio → Cervarix Group, Cervarix + Boostrix Polio Group | Intervention Type: BIOLOGICAL; Name: GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM); Assigned to Arm(s): Boostrix Polio → Cervarix Group, Cervarix + Boostrix Polio Group, Cervarix Group

Answer: C