NCT05163847

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: FluGen Inc · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Influenza Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Cam2020 M2SR H3N2 influenza vaccine	Administered intranasally on Day 1
BIOLOGICAL	Fluzone HD IIV	Administered intramuscularly on Day 1
OTHER	IN Placebo	Administered intranasally on Day 1
OTHER	IM Placebo	Administered intramuscularly on Day 1

Timeline

• Start date: 2022-06-14
• Primary completion: 2022-11-03
• Completion: 2022-11-03
• First posted: 2021-12-20
• Last updated: 2022-11-14

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study