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

Influenza Vaccine Clinical Trial

Official title:
Phase 1b Study to Investigate the Safety and Immunogenicity of Cam2020 (A/Cambodia/e0826360/2020) M2SR H3N2 Monovalent Influenza Vaccine Administered Alone or With Licensed, Inactivated Influenza Vaccine in Adults 65 to 85 Years Old

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05163847
Study type Interventional
Source FluGen Inc
Contact
Status Completed
Phase Phase 1
Start date June 14, 2022
Completion date November 3, 2022
View Details
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