D2560C00015 FluMist Annual Safety Study 2018
Study identifier:D2560C00015
ClinicalTrials.gov identifier:NCT03564444
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 4, Randomized, Double-blind, Placebo controlled Study to Evaluate the Safety of 2 New of 6:2 Influenza Virus Reassortants in Adults
Medical condition
Influenza, Healthy
Phase
Phase 4
Healthy volunteers
Yes
Study drug
-
Sex
All
Actual Enrollment
300
Study type
Interventional
Age
18 Years - 49 Years
Date
Study Start Date: 06 Jun 2018
Primary Completion Date: 27 Dec 2018
Study Completion Date: 27 Dec 2018
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention
Verification:
Verified 01 Dec 2019 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bivalent influenza vaccine A single dose of bivalent vaccine (10^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1 | Biological/Vaccine: Bivalent influenza vaccine A single dose of bivalent vaccine (10^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1. |
| Placebo Comparator: Placebo A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1. | Other: Placebo A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1. |
Contacts
Investigators
Principal Investigator
Nathan Segall
Clinical Research Atlanta
