Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB01L1 in Healthy Volunteers
Brief Summary: The purpose of this phase I trial is to evaluate safety and tolerability of GHB01L1 administered as single dose intranasal aerosol for vaccination against influenza A (H1N1) virus.

This study is performed further to assess local and systemic immune response and to analyse pharmacokinetics (shedding) of a single dose GHB01L1 aerosol administered intranasally.


Options:
A: Arm Label: TIV + aH5N1; Type: EXPERIMENTAL; Interventions: Biological: Trivalent influenza virus vaccine (TIV), Biological: Adjuvanted monovalent influenza virus vaccine (aH5N1) | Arm Label: PL + aTIV; Type: ACTIVE_COMPARATOR; Interventions: Biological: Placebo (PL), Biological: Adjuvanted trivalent influenza virus vaccine (aTIV) | Intervention Type: BIOLOGICAL; Name: Placebo (PL); Assigned to Arm(s): PL + aTIV | Intervention Type: BIOLOGICAL; Name: Trivalent influenza virus vaccine (TIV); Assigned to Arm(s): TIV + aH5N1 | Intervention Type: BIOLOGICAL; Name: Adjuvanted monovalent influenza virus vaccine (aH5N1); Assigned to Arm(s): TIV + aH5N1 | Intervention Type: BIOLOGICAL; Name: Adjuvanted trivalent influenza virus vaccine (aTIV); Assigned to Arm(s): PL + aTIV
B: Arm Label: A/H1N1 Vaccine Group 1; Type: EXPERIMENTAL; Interventions: Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA) | Arm Label: A/H1N1 Vaccine Group 2; Type: EXPERIMENTAL; Interventions: Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA) | Arm Label: A/H1N1 Vaccine Group 3; Type: EXPERIMENTAL; Interventions: Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA) | Arm Label: Placebo Group; Type: PLACEBO_COMPARATOR; Interventions: Biological: Normal saline solution (placebo) | Intervention Type: BIOLOGICAL; Name: Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA); Assigned to Arm(s): A/H1N1 Vaccine Group 1 | Intervention Type: BIOLOGICAL; Name: Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA); Assigned to Arm(s): A/H1N1 Vaccine Group 2 | Intervention Type: BIOLOGICAL; Name: Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA); Assigned to Arm(s): A/H1N1 Vaccine Group 3 | Intervention Type: BIOLOGICAL; Name: Normal saline solution (placebo); Assigned to Arm(s): Placebo Group
C: Arm Label: cohort I; Type: OTHER; Interventions: Biological: GHB01L1 | Arm Label: cohort II; Type: OTHER; Interventions: Biological: GHB01L1 | Arm Label: cohort III; Type: OTHER; Interventions: Biological: GHB01L1 | Arm Label: cohort IV; Type: OTHER; Interventions: Biological: GHB01L1 | Arm Label: cohort V; Type: OTHER; Interventions: Biological: GHB01L1 | Intervention Type: BIOLOGICAL; Name: GHB01L1; Assigned to Arm(s): cohort I, cohort II, cohort III, cohort IV, cohort V
D: Arm Label: Group 4: Placebo: Intramuscular; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: Group 3: Placebo: Nasal; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: Group 1: FluMist™; Type: EXPERIMENTAL; Interventions: Biological: Cold-adapted live attenuated influenza virus vaccine, trivalent | Arm Label: Group 2: Fluzone®/Fluvirin; Type: EXPERIMENTAL; Interventions: Biological: Trivalent inactivated influenza vaccine | Intervention Type: BIOLOGICAL; Name: Cold-adapted live attenuated influenza virus vaccine, trivalent; Assigned to Arm(s): Group 1: FluMist™ | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Group 4: Placebo: Intramuscular | Intervention Type: BIOLOGICAL; Name: Trivalent inactivated influenza vaccine; Assigned to Arm(s): Group 2: Fluzone®/Fluvirin | Intervention Type: BIOLOGICAL; Name: Trivalent inactivated influenza vaccine; Assigned to Arm(s): Group 2: Fluzone®/Fluvirin | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Group 3: Placebo: Nasal

Answer: C