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A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults

NCT07464314 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2026-03-27

No results posted yet for this study

Summary

This early-stage study will look at a new mRNA vaccine that combines defenses against both seasonal flu and COVID-19 in terms of its safety and how it builds protection. Healthy adults aged 65 to 85 will receive different doses of this new vaccine, a standard flu vaccine, or COVID-19 vaccine. The study will assess any side effects or health issues, and additional blood samples will be collected at specific times to evaluate how well participants bodies build protection against the flu and COVID-19.

Conditions

  • Influenza, Human+COVID-19

Interventions

BIOLOGICAL

Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine

Flu/COVm Vaccine with multiple dose levels (Dose Level 1, Dose Level 2, and Dose Level 3), will be administered via single intramuscular injection.

BIOLOGICAL

Licensed Seasonal Influenza Vaccine

License Seasonal Influenza Vaccine will be administered as a single intramuscular dose.

BIOLOGICAL

Licensed COVID-19 Vaccine

Licensed COVID-19 Vaccine will be administered as a single intramuscular dose.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2026-12-03
Completion
2027-06-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT07464314 on ClinicalTrials.gov