NCT03845231View on ClinicalTrials.gov

Mucosal and Systemic Immunity After Viral Challenge of Healthy Volunteers Vaccinated With Inactivated Influenza Vaccine Via the Intranasal Versus Intramuscular Route

PHASE2CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

April 29, 2019

Primary Completion Date

December 20, 2019

Study Completion Date

October 28, 2020

Conditions
Influenza
Interventions
BIOLOGICAL

Flucelvax(R)

Cohort 1 will receive IM quadrivalent IIV (Flucelvax (R)) at the standard dose of 15 micrograms HA per strain (60 micrograms HA total).

OTHER

Human Challenge virus

A dose of 10\^7 50% tissue culture infective dose (TCID50) of human challenge virus will be administered intranasally to all participants using a nasal sprayer.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03845231 - Mucosal and Systemic Immunity After Viral Challenge of Healthy Volunteers Vaccinated With Inactivated Influenza Vaccine Via the Intranasal Versus Intramuscular Route | Biotech Hunter | Biotech Hunter