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Cancer Vaccine

mRNA Vaccine for Flu/COVID-19

Phase 3

Waitlist Available

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.

Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled nasal and topical steroids are allowed.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 29

Awards & highlights

Pivotal Trial

Summary

This trial studies the safety and effectiveness of two vaccines against influenza and SARS-CoV-2, in adults aged 50-65 and over 65.

Who is the study for?

This trial is for healthy adults aged 50 and above who have completed their COVID-19 vaccination series at least 90 days prior. Women of childbearing age must not be pregnant, use contraception, or abstain from pregnancy-causing activities. Exclusions include recent blood donors, those with conditions affecting study participation or interpretation, immunosuppressant users, the acutely ill or febrile, recent vaccine recipients, and those exposed to flu or COVID-19.

What is being tested?

The trial tests mRNA-1083's effectiveness against both SARS-CoV-2 and influenza compared to licensed vaccines in two age groups: adults over 65 (Cohort A) and those between 50 to under 65 (Cohort B). It measures immune response safety and reaction to the vaccine.

What are the potential side effects?

Potential side effects may include typical vaccine reactions such as soreness at injection site, fatigue, headache, muscle pain, chills feverish feelings which are usually mild to moderate in intensity.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had, nor plan to have, any vaccines around the time of the study injections.

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I have been on strong immune system medications for more than 14 days in the last 6 months.

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I have been in close contact with a COVID-19 case as per CDC guidelines in the last 10 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay

SARS-CoV-2: Number of Participants with Seroresponse, as Measured by PsVNA

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Cohort B1: mRNA-1083 and PlaceboExperimental Treatment2 Interventions

Participants of age 50 to \<65 years will receive mRNA-1083 and placebo administered as 2 IM injections of on Day 1.

Group II: Cohort A1: mRNA-1083 and PlaceboExperimental Treatment2 Interventions

Participants of age 65 years and older will receive mRNA-1083 and placebo administered as 2 intramuscular (IM) injections of on Day 1.

Group III: Cohort A2: Influenza Vaccine and COVID-19 VaccineActive Control2 Interventions

Participants of age 65 years and older will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.

Group IV: Cohort B2: Influenza Vaccine and COVID-19 VaccineActive Control2 Interventions

Participants of age 50 to \<65 years will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

mRNA-1083

2023

Completed Phase 3

~8080