Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Double Blind, Controlled by Conventional BCG, Dose-escalation Phase I Study, to Evaluate Safety, Tolerability and Immunogenicity of a Mycobacterium Bovis BCG (Bacillus Calmette-Guérin) Vaccine, 1331 Danish Strain, Live Attenuated and Recombinant for the Expression of Human Respiratory Syncytial Virus Nucleoprotein (N) in Healthy Males Within 18 and 50 Years of Age
Brief Summary: Human respiratory syncytial virus (hRSV) is the main cause of lower respiratory tract infection in children under one year of age. This study will evaluate the safety, tolerability and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine that expresses the human Respiratory Syncytial Virus Nucleoprotein (N), in adult males (18 to 50 years of age).


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Biological: MEDI-534 | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Biological: MEDI-534 | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Biological: MEDI-534 | Intervention Type: BIOLOGICAL; Name: MEDI-534; Assigned to Arm(s): 1 | Intervention Type: BIOLOGICAL; Name: MEDI-534; Assigned to Arm(s): 2 | Intervention Type: BIOLOGICAL; Name: MEDI-534; Assigned to Arm(s): 3
B: Arm Label: Conventional BCG full dose; Type: ACTIVE_COMPARATOR; Interventions: Biological: Conventional BCG full dose | Arm Label: rBCG-N-hRSV 1/100 dose; Type: EXPERIMENTAL; Interventions: Biological: rBCG-N-hRSV 1/100 | Arm Label: rBCG-N-hRSV 1/10 dose; Type: EXPERIMENTAL; Interventions: Biological: rBCG-N-hRSV 1/10 | Arm Label: rBCG-N-hRSV full dose; Type: EXPERIMENTAL; Interventions: Biological: rBCG-N-hRSV full dose | Intervention Type: BIOLOGICAL; Name: rBCG-N-hRSV 1/100; Assigned to Arm(s): rBCG-N-hRSV 1/100 dose | Intervention Type: BIOLOGICAL; Name: rBCG-N-hRSV 1/10; Assigned to Arm(s): rBCG-N-hRSV 1/10 dose | Intervention Type: BIOLOGICAL; Name: rBCG-N-hRSV full dose; Assigned to Arm(s): rBCG-N-hRSV full dose | Intervention Type: BIOLOGICAL; Name: Conventional BCG full dose; Assigned to Arm(s): Conventional BCG full dose
C: Arm Label: Vitamin D and gargling; Type: EXPERIMENTAL; Interventions: Dietary Supplement: cholecalciferol (vitamin D3), Behavioral: Gargling | Arm Label: Vitamin D and general health advice; Type: EXPERIMENTAL; Interventions: Dietary Supplement: cholecalciferol (vitamin D3) | Arm Label: Placebo and general health advice; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Arm Label: Placebo and gargling; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Gargling, Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: cholecalciferol (vitamin D3); Assigned to Arm(s): Vitamin D and gargling, Vitamin D and general health advice | Intervention Type: BEHAVIORAL; Name: Gargling; Assigned to Arm(s): Placebo and gargling, Vitamin D and gargling | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo and gargling, Placebo and general health advice
D: Arm Label: 1; Type: OTHER; Interventions: Other: Control | Arm Label: 2; Type: OTHER; Interventions: Device: Masks | Arm Label: 3; Type: OTHER; Interventions: Device: Masks & hand hygiene | Intervention Type: DEVICE; Name: Masks; Assigned to Arm(s): 2 | Intervention Type: DEVICE; Name: Masks & hand hygiene; Assigned to Arm(s): 3 | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): 1

Answer: B