Study identifier:D2560C00012
ClinicalTrials.gov identifier:NCT02743117
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults
Influenza, Healthy
Phase 4
Yes
-
All
301
Interventional
18 Years - 49 Years
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verified 01 Oct 2017 by MedImmune, LLC
MedImmune, LLC
AstraZeneca
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Monovalent Influenza Vaccine A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1. | Biological/Vaccine: Monovalent Influenza Vaccine A single dose of 10^(7.0 ± 0.5) FFU strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1. |
Placebo Comparator: Placebo A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1. | Other: Placebo A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1. |