Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 1 Randomized, Observer Blind, Placebo Controlled, Dosage-Escalation Single Center Study to Evaluate the Safety and Immunogenicity of an RSV Fusion Glycoprotein (F) Subunit Vaccine in Healthy Adults
Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of two doses of the investigational RSV F subunit vaccine administered intramuscularly (IM). In this current Phase 1, first-in-human study, the three different antigen amounts that have been selected will be evaluated in a stepwise manner in three different cohorts (Cohort 1: low dosage of RSV F subunit vaccine, Cohort 2: middle dosage of RSV F subunit vaccine, and Cohort 3: high dosage of RSV F subunit vaccine). In addition, the effect of an adjuvant, either aluminum hydroxide or MF59, and antibody kinetics post-vaccination at different time points will be evaluated as compared to unadjuvanted RSV F subunit vaccine at the same dosage levels.


Options:
A: Arm Label: Vaccine arm; Type: ACTIVE_COMPARATOR; Interventions: Biological: ShanChol | Arm Label: Vaccine plus hygiene and safe water arm; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Vaccine and behaviour | Arm Label: Non-intervention arm; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BIOLOGICAL; Name: ShanChol; Assigned to Arm(s): Vaccine arm | Intervention Type: BEHAVIORAL; Name: Vaccine and behaviour; Assigned to Arm(s): Vaccine plus hygiene and safe water arm
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Soap | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Soap; Assigned to Arm(s): 1
C: 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
D: Arm Label: RSV F 45 No Adj Group; Type: EXPERIMENTAL; Interventions: Biological: RSV F subunit 45 μg No adjuvant | Arm Label: RSV F 45 Alum Adj Group; Type: EXPERIMENTAL; Interventions: Biological: RSV F subunit 45 μg Aluminum hydroxide adjuvant | Arm Label: RSV F 45 MF59 Adj Group; Type: EXPERIMENTAL; Interventions: Biological: RSV F subunit 45 μg MF59 adjuvant | Arm Label: Placebo 1 Group; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: RSV F 90 No Adj Group; Type: EXPERIMENTAL; Interventions: Biological: RSV F subunit 90 μg No adjuvant | Arm Label: RSV F 90 Alum Adj Group; Type: EXPERIMENTAL; Interventions: Biological: RSV F subunit 90 μg Aluminum hydroxide adjuvant | Arm Label: RSV F 90 MF59 Adj Group; Type: EXPERIMENTAL; Interventions: Biological: RSV F subunit 90 μg MF59 adjuvant | Arm Label: Placebo 2 Group; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: RSV F 135 No Adj Group; Type: EXPERIMENTAL; Interventions: Biological: RSV F subunit 135 μg No adjuvant | Arm Label: RSV F 135 Alum Adj Group; Type: EXPERIMENTAL; Interventions: Biological: RSV F subunit 135 μg Aluminum hydroxide adjuvant | Arm Label: RSV F 135 MF59 Adj Group; Type: EXPERIMENTAL; Interventions: Biological: RSV F subunit 135 μg MF59 adjuvant | Arm Label: Placebo 3 Group; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: BIOLOGICAL; Name: RSV F subunit 45 μg No adjuvant; Assigned to Arm(s): RSV F 45 No Adj Group | Intervention Type: BIOLOGICAL; Name: RSV F subunit 45 μg Aluminum hydroxide adjuvant; Assigned to Arm(s): RSV F 45 Alum Adj Group | Intervention Type: BIOLOGICAL; Name: RSV F subunit 45 μg MF59 adjuvant; Assigned to Arm(s): RSV F 45 MF59 Adj Group | Intervention Type: BIOLOGICAL; Name: RSV F subunit 90 μg No adjuvant; Assigned to Arm(s): RSV F 90 No Adj Group | Intervention Type: BIOLOGICAL; Name: RSV F subunit 90 μg Aluminum hydroxide adjuvant; Assigned to Arm(s): RSV F 90 Alum Adj Group | Intervention Type: BIOLOGICAL; Name: RSV F subunit 90 μg MF59 adjuvant; Assigned to Arm(s): RSV F 90 MF59 Adj Group | Intervention Type: BIOLOGICAL; Name: RSV F subunit 135 μg No adjuvant; Assigned to Arm(s): RSV F 135 No Adj Group | Intervention Type: BIOLOGICAL; Name: RSV F subunit 135 μg Aluminum hydroxide adjuvant; Assigned to Arm(s): RSV F 135 Alum Adj Group | Intervention Type: BIOLOGICAL; Name: RSV F subunit 135 μg MF59 adjuvant; Assigned to Arm(s): RSV F 135 MF59 Adj Group | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo 1 Group, Placebo 2 Group, Placebo 3 Group

Answer: D