This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with inactivated influenza vaccine (IIV) delivered IM to a healthy adult population age 65 to 85 years at time of enrollment.
This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with IIV delivered IM to a healthy adult population age 65 to 85 years at time of enrollment. Eligible subjects will be randomized concurrently in a 3:3:3:1 ratio to receive one administration of Cam2020 M2SR alone (Cohort 1, n=90), Cam2020 M2SR along with IIV (Cohort 2, n=90), IIV alone (Cohort 3, n=90), or placebo (Cohort 4, n=30).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
303
Administered intranasally on Day 1
Administered intramuscularly on Day 1
Administered intranasally on Day 1
United Medical Research
Port Orange, Florida, United States
Velocity Clinical Research
Meridian, Idaho, United States
Johnson County Clin Trials
Lenexa, Kansas, United States
Rochester Clinical Research
Rochester, New York, United States
Solicited AEs during 7 days after experimental treatment
The number and percentage of subjects who experience solicited local and systemic reactions during the 7 days after vaccine administration of M2SR administration alone or with IIV
Time frame: Day 1 to Day 8
Unsolicited AEs during 28 days after experimental treatment
The number and percentage of subjects who experience unsolicited AEs during the 28 days after vaccine administration of M2SR alone or with IIV.
Time frame: Day 1 to Day 29
SAEs through 28 days after experimental treatment
The number and percentage of subjects who experience SAEs from the time of informed consent through 28 days after vaccine administration of M2SR alone or with IIV.
Time frame: Day 1 to Day 29
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Administered intramuscularly on Day 1
Velocity Clinical Research
Beechwood, Ohio, United States
Velocity Clinical Research
Cedar Park, Texas, United States