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A Study of an Investigational Flu Seasonal/SARS-CoV-2 Combination Vaccine in Adults

NCT06680375 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-09-11

No results posted yet for this study

Summary

This study will evaluate the reactogenicity, safety, and immune response of Flu Seasonal/SARS-CoV-2 mRNA (mRNA Flu/COVID-19) combination vaccine. The flu portion will target multiple strains of the flu virus, while the COVID-19 part will focus on the spike protein of the SARS-CoV-2 virus. Both parts of this vaccine have been tested individually before. This will be the first study to test the combined vaccine in humans in healthy adult participants.

Conditions

Interventions

COMBINATION_PRODUCT

Flu Seasonal /SARS-CoV-2 mRNA Dose 1

A Flu mRNA vaccine composition in combination with Dose 1 of a COVID-19 component will be administered.

COMBINATION_PRODUCT

Flu Seasonal /SARS-CoV-2 mRNA Dose 2

A Flu mRNA vaccine composition in combination with Dose 2 of a COVID-19 component will be administered.

COMBINATION_PRODUCT

Flu Seasonal mRNA

An investigational mRNA Flu Seasonal vaccine will be administered.

COMBINATION_PRODUCT

SARS-CoV-2 mRNA Dose 1

Dose 1 of an investigational mRNA COVID-19 vaccine will be administered.

COMBINATION_PRODUCT

SARS-CoV-2 mRNA Dose 2

Dose 2 of an investigational mRNA COVID-19 vaccine will be administered.

COMBINATION_PRODUCT

Licensed Flu Seasonal

A licensed Flu Seasonal vaccine will be administered.

COMBINATION_PRODUCT

Licensed COVID-19 mRNA

A licensed mRNA COVID-19 vaccine will be administered.

DRUG

Placebo

A placebo will be administered.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2025-06-09
Completion
2025-06-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT06680375 on ClinicalTrials.gov