Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults

  • STATUS
    Not Recruiting
  • End date
    Mar 10, 2023
  • participants needed
    300
  • sponsor
    FluGen Inc
Updated on 20 October 2022
trivalent influenza vaccine
fluzone
Accepts healthy volunteers

Summary

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.

Description

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).

Details
Condition Influenza Vaccine
Treatment IM Placebo, IN Placebo, Cam2020 M2SR H3N2 influenza vaccine, Fluzone HD IIV
Clinical Study IdentifierNCT05163847
SponsorFluGen Inc
Last Modified on20 October 2022

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