Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Observer-blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency, Immunogenicity, and Safety of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Healthy Adults 18-49 Years of Age
Brief Summary: This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.


Options:
A: Arm Label: Quadrivalent VLP Influenza Vaccine - Lot 1; Type: EXPERIMENTAL; Interventions: Biological: Quadrivalent VLP Influenza Vaccine | Arm Label: Quadrivalent VLP Influenza Vaccine - Lot 2; Type: EXPERIMENTAL; Interventions: Biological: Quadrivalent VLP Influenza Vaccine | Arm Label: Quadrivalent VLP Influenza Vaccine - Lot 3; Type: EXPERIMENTAL; Interventions: Biological: Quadrivalent VLP Influenza Vaccine | Intervention Type: BIOLOGICAL; Name: Quadrivalent VLP Influenza Vaccine; Assigned to Arm(s): Quadrivalent VLP Influenza Vaccine - Lot 1, Quadrivalent VLP Influenza Vaccine - Lot 2, Quadrivalent VLP Influenza Vaccine - Lot 3
B: Arm Label: Tocilizumab (TCZ) Arm; Type: EXPERIMENTAL; Interventions: Drug: Tocilizumab (TCZ) | Arm Label: Placebo Arm; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Tocilizumab (TCZ); Assigned to Arm(s): Tocilizumab (TCZ) Arm | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo Arm
C: Arm Label: Part 1: Tocilizumab qw + 26 weeks prednisone taper; Type: EXPERIMENTAL; Interventions: Drug: Tocilizumab, Drug: Prednisone, Drug: Prednisone Placebo | Arm Label: Part 1: Tocilizumab q2w + 26 weeks prednisone taper; Type: EXPERIMENTAL; Interventions: Drug: Tocilizumab, Drug: Prednisone, Drug: Tocilizumab Placebo, Drug: Prednisone Placebo | Arm Label: Part 1: Placebo + 26 weeks prednisone taper; Type: PLACEBO_COMPARATOR; Interventions: Drug: Prednisone, Drug: Tocilizumab Placebo, Drug: Prednisone Placebo | Arm Label: Part 1: Placebo + 52 weeks prednisone taper; Type: PLACEBO_COMPARATOR; Interventions: Drug: Prednisone, Drug: Tocilizumab Placebo, Drug: Prednisone Placebo | Arm Label: Part 2: Open-Label Tocilizumab qw; Type: EXPERIMENTAL; Interventions: Drug: Tocilizumab, Drug: Corticosteroids, Drug: Methotrexate | Intervention Type: DRUG; Name: Tocilizumab; Assigned to Arm(s): Part 1: Tocilizumab q2w + 26 weeks prednisone taper, Part 1: Tocilizumab qw + 26 weeks prednisone taper, Part 2: Open-Label Tocilizumab qw | Intervention Type: DRUG; Name: Prednisone; Assigned to Arm(s): Part 1: Placebo + 26 weeks prednisone taper, Part 1: Placebo + 52 weeks prednisone taper, Part 1: Tocilizumab q2w + 26 weeks prednisone taper, Part 1: Tocilizumab qw + 26 weeks prednisone taper | Intervention Type: DRUG; Name: Tocilizumab Placebo; Assigned to Arm(s): Part 1: Placebo + 26 weeks prednisone taper, Part 1: Placebo + 52 weeks prednisone taper, Part 1: Tocilizumab q2w + 26 weeks prednisone taper | Intervention Type: DRUG; Name: Prednisone Placebo; Assigned to Arm(s): Part 1: Placebo + 26 weeks prednisone taper, Part 1: Placebo + 52 weeks prednisone taper, Part 1: Tocilizumab q2w + 26 weeks prednisone taper, Part 1: Tocilizumab qw + 26 weeks prednisone taper | Intervention Type: DRUG; Name: Corticosteroids; Assigned to Arm(s): Part 2: Open-Label Tocilizumab qw | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): Part 2: Open-Label Tocilizumab qw
D: Arm Label: No face mask; Type: ACTIVE_COMPARATOR; Interventions: Other: Progressive cycling exercise test to exhaustion | Arm Label: Disposable face mask; Type: EXPERIMENTAL; Interventions: Other: Progressive cycling exercise test to exhaustion | Arm Label: Cloth face mask; Type: EXPERIMENTAL; Interventions: Other: Progressive cycling exercise test to exhaustion | Intervention Type: OTHER; Name: Progressive cycling exercise test to exhaustion; Assigned to Arm(s): Cloth face mask, Disposable face mask, No face mask

Answer: A