Study identifier:D2560C00014
ClinicalTrials.gov identifier:N/A
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
300
Interventional
18 Years - 49 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verified 01 Dec 2018 by MedImmune, LLC
MedImmune, LLC
AstraZeneca
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Monovalent Influenza Vaccine Participants will receive a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strain] by intranasal spray on Day 1. | Biological/Vaccine: Monovalent Influenza Vaccine A single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 FFU of each of 1 ca, att, ts 6:2 reassortant influenza strain] will be administered as intranasal spray on Day 1. |
Placebo Comparator: Placebo Participants will receive a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1. | Other: Placebo A single dose of placebo matching with monovalent influenza vaccine will be administered as intranasal spray on Day 1. |