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

NCT05163847 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2022-11-14

No results posted yet for this study

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.

Conditions

  • Influenza Vaccine

Interventions

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • FluGen Inc

    lead INDUSTRY

Principal Investigators

  • Pamuk Bilsel · FluGen Inc

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2022-11-03
Completion
2022-11-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05163847 on ClinicalTrials.gov