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Vaccine

A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old

Phase 1 & 2
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 29 (28 days post vaccination)
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial is testing a new vaccine called mRNA-1073 in healthy people to see if it is safe and effective. The vaccine works by teaching the body to recognize and fight the virus using a small, harmless piece of it. mRNA vaccines have been proven to work efficiently, have high potency, and can be rapidly developed and deployed, which is critical for quick responses in the case of a pandemic.

Eligible Conditions
  • Influenza
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 29 (28 days post vaccination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 29 (28 days post vaccination) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation
Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs)
Number of Participants With Unsolicited Adverse Events (AEs)
Secondary study objectives
Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2
Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
+2 more

Side effects data

From 2022 Phase 1 & 2 trial • 550 Patients • NCT05375838
88%
Injection site pain
78%
Fatigue
72%
Myalgia
63%
Headache
50%
Chills
49%
Arthralgia
25%
Injection site lymphadenopathy
23%
Vomiting
20%
Pyrexia
11%
COVID-19
9%
Rhinovirus infection
4%
Injection site induration
2%
Injection site erythema
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
mRNA-1273 + Placebo
mRNA-1010 + Placebo
mRNA-1010 + mRNA-1273
Dose A: mRNA-1073 Low Dose + Placebo
Dose B: mRNA-1073 Medium Dose + Placebo
Dose C: mRNA-1073 High Dose + Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

6Treatment groups
Experimental Treatment
Group I: mRNA-1273 Plus PlaceboExperimental Treatment2 Interventions
Participants will receive 2 intramuscular (IM) injections, one in each arm, of mRNA-1273 plus placebo at the specified dose level on Day 1.
Group II: mRNA-1010 Plus mRNA-1273Experimental Treatment1 Intervention
Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus mRNA-1273 at the specified dose level on Day 1.
Group III: mRNA-1010 Plus PlaceboExperimental Treatment2 Interventions
Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus placebo at the specified dose level on Day 1.
Group IV: Dose C: mRNA-1073 Plus PlaceboExperimental Treatment2 Interventions
Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.
Group V: Dose B: mRNA-1073 Plus PlaceboExperimental Treatment2 Interventions
Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.
Group VI: Dose A: mRNA-1073 Plus PlaceboExperimental Treatment2 Interventions
Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moderna COVID-19 Vaccine
FDA approved
mRNA-1073
2022
Completed Phase 2
~550
mRNA-1010
2022
Completed Phase 3
~40020
Placebo
1995
Completed Phase 3
~2670

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
120 Previous Clinical Trials
61,587,659 Total Patients Enrolled
41 Trials studying COVID-19
61,383,755 Patients Enrolled for COVID-19
~153 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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