Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
Brief Summary: The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months.

Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the usual timing control group (C):

H0: δ ≤ -δ0 versus H1: δ \> -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin


Options:
A: 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
B: Arm Label: 12 months; Type: EXPERIMENTAL; Interventions: Biological: quadrivalent human papillomavirus vaccine | Arm Label: 6 month; Type: ACTIVE_COMPARATOR; Interventions: Biological: quadrivalent human papillomavirus vaccine | Intervention Type: BIOLOGICAL; Name: quadrivalent human papillomavirus vaccine; Assigned to Arm(s): 12 months | Intervention Type: BIOLOGICAL; Name: quadrivalent human papillomavirus vaccine; Assigned to Arm(s): 6 month
C: Arm Label: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine; Type: EXPERIMENTAL; Interventions: Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20 | Arm Label: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40; Type: EXPERIMENTAL; Interventions: Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40 | Arm Label: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80; Type: EXPERIMENTAL; Interventions: Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80 | Arm Label: Placebo (mcg) (Aluminum Adjuvant) 225; Type: EXPERIMENTAL; Interventions: Biological: Placebo (mcg) (Aluminum Adjuvant)225 | Arm Label: Placebo (mcg) (Aluminum Adjuvant) 450; Type: EXPERIMENTAL; Interventions: Biological: Placebo (mcg) (Aluminum Adjuvant) 450 | Intervention Type: BIOLOGICAL; Name: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20; Assigned to Arm(s): Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine | Intervention Type: BIOLOGICAL; Name: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40; Assigned to Arm(s): Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40 | Intervention Type: BIOLOGICAL; Name: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80; Assigned to Arm(s): Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80 | Intervention Type: BIOLOGICAL; Name: Placebo (mcg) (Aluminum Adjuvant)225; Assigned to Arm(s): Placebo (mcg) (Aluminum Adjuvant) 225 | Intervention Type: BIOLOGICAL; Name: Placebo (mcg) (Aluminum Adjuvant) 450; Assigned to Arm(s): Placebo (mcg) (Aluminum Adjuvant) 450
D: Arm Label: Group A; Type: EXPERIMENTAL; Interventions: Biological: GSK Biologicals' HPV vaccine (GSK1674330A) | Arm Label: Group B; Type: EXPERIMENTAL; Interventions: Biological: GSK Biologicals' HPV vaccine (GSK1674330A) | Arm Label: Group C; Type: EXPERIMENTAL; Interventions: Biological: GSK Biologicals' HPV vaccine (GSK1674330A) | Arm Label: Group D; Type: EXPERIMENTAL; Interventions: Biological: GSK Biologicals' HPV vaccine (GSK1674330A) | Arm Label: Group E; Type: EXPERIMENTAL; Interventions: Biological: GSK Biologicals' HPV vaccine (GSK1674330A) | Arm Label: Group F; Type: ACTIVE_COMPARATOR; Interventions: Biological: Cervarix TM | Intervention Type: BIOLOGICAL; Name: GSK Biologicals' HPV vaccine (GSK1674330A); Assigned to Arm(s): Group A, Group B, Group C, Group D, Group E | Intervention Type: BIOLOGICAL; Name: Cervarix TM; Assigned to Arm(s): Group F

Answer: B