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SARS-CoV-2Phase 1NCT05397223

A Study of Modified mRNA Vaccines in Healthy Adults

A Phase 1 study testing mRNA-1273, mRNA-1010 and mRNA-1345 in people with SARS-CoV-2 and Seasonal Influenza, run by ModernaTX, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
mRNA-1273, mRNA-1010 and mRNA-1345
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
8 sitesUnited States
Study dates
24 May 2022to 27 Feb 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults 18 to 75 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening. For mRNA-1647 study arms, adults 18 to <50 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening.
  • Body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the screening visit.

Who cannot join

  • Participant has had close contact to someone with confirmed SARS-CoV-2, respiratory syncytial virus (RSV), or influenza infection in the past 14 days prior to the screening visit.
  • Severe allergic reaction to any component of the FLUAD vaccine (active comparator), including egg protein, or after a previous dose of any influenza vaccine.
  • Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (to include any systemic corticosteroids) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
  • Participant plans to receive any licensed or authorized vaccine, including COVID-19 influenza vaccines, within 28 days before or after any study injection.
  • Participant has received a NH 2021 - 2022 or 2022-2023 seasonal influenza vaccine or any other influenza vaccine, or an experimental RSV or cytomegalovirus (CMV) vaccine, within 6 months prior to study Day 1, and/or has not completed a primary vaccination series for COVID-19.
  • Participant has received an authorized or approved COVID-19 vaccine within 4 months prior to Day 1, and/or has not completed a primary vaccination series for COVID-19.
Show all 10Show fewer
  • Participant had a laboratory-confirmed infection with influenza or RSV within 6 months prior to Day 1, or SARS-CoV-2 within 4 months of Day 1. SARS-CoV-2 infection confirmed with self-administered, authorized or approved rapid antigen test is acceptable.
  • Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study.
  • Participated in an interventional clinical study within 28 days prior to the screening visit based on the medical history interview or plans to do so while participating in this study until 12 months after their last study vaccination.
  • Other inclusion and exclusion criteria may apply.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Benchmark Research

    Austin, Texas, 78705

  • Tekton Research, Inc

    Austin, Texas, 78745

  • CenExel

    Hollywood, Florida, 33024

  • DM Clinical Research- Texas Center for Drug Development

    Houston, Texas, 77081

  • Johnson County Clinical Trials

    Lenexa, Kansas, 66219

  • Meridian Clinical Research

    Lincoln, Nebraska, 68510

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Meridian Clinical Research

    Sioux City, Iowa, 51106

Other trials in United States

About this study

Official title: Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Modified mRNA Vaccines Using a Systems Biology Approach in Healthy Adults

The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.

Being tested
mRNA-1273, mRNA-1010, mRNA-1345, FLUAD®, mRNA-1647
Keywords
mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna, Influenza vaccine, mRNA-1010, mRNA-1345, Respiratory syncytial virus, RSV Seropositive, Vaccines, mRNA-1647, Cytomegalovirus, CMV, Cytomegalovirus Vaccine
Medical subject headings
Coronavirus Infections, Virus Diseases, COVID-19, Influenza, Human, Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1273Biological

    Sterile liquid for injection

  • mRNA-1010Biological

    Sterile liquid for injection

  • mRNA-1345Biological

    Sterile liquid for injection

  • FLUAD®Biological

    adjuvanted (MF59), inactivated, quadrivalent seasonal influenza vaccine

  • mRNA-1647Biological

    Sterile lyophilized product

Study groups in NCT05397223
Study groupRoleWhat they receive
Part 1: mRNA-1345ExperimentalParticipants will receive single intramuscular (IM) injection of mRNA-1345 on Day 1.
Receives: Biological: mRNA-1345
Part 1: mRNA-1647 2-DoseExperimentalParticipants will receive single IM injection of mRNA-1647 on Days 1 and 57.
Receives: Biological: mRNA-1647
Part 1: mRNA-1647 3-DoseExperimentalParticipants will receive single IM injection of mRNA-1647 on Days 1, 57, and 169.
Receives: Biological: mRNA-1647
Part 2: mRNA-1273ExperimentalParticipants will receive single IM injection of mRNA-1273 on Day 1
Receives: Biological: mRNA-1273
Part 2: mRNA-1010ExperimentalParticipants will receive single IM injection of mRNA-1010 on Day 1.
Receives: Biological: mRNA-1010
Part 2: FLUAD®Active comparatorParticipants will receive single IM injection of FLUAD® on Day 1.
Receives: Biological: FLUAD®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

    Measured: Up to Day 176 (7 days follow-up post-vaccination)

  2. Number of Participants With Unsolicited Adverse Events (AEs)

    Measured: Up to Day 197 (28 days follow-up post-vaccination)

  3. Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination

    Measured: Day 1 through end of study (EOS) (up to Day 1249)

  4. Number of Participants with Medically Attended Adverse Events (MAAEs)

    Measured: Day 1 through Day 361

Secondary outcomes (3)

  1. Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345

    Measured: Days 1 (Baseline), 29, 85, and 197

  2. Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345

    Measured: Days 1 (Baseline), 29, 85, and 197

  3. Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, mRNA-1345, and mRNA-1647

    Measured: Days 1 (Baseline), 29, 85, and 197

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2022
  2. Study start24 May 2022
  3. Primary completion27 Feb 2026
  4. Study completion27 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05397223
Sponsor's protocol ID
mRNA-CRID-001
Status last verified
Mar 2026
First submitted
25 May 2022
Last updated
12 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Henry C, Makrinos D, Liu R, Cavallaro M, Fenderson B, Sun Y, Chang X, Astley E, Girard B, Yu WH, Oostendorp J, DiPiazza A, Paris R. An mRNA influenza vaccine induces immunity comparable to an adjuvanted vaccine in a randomized trial. NPJ Vaccines. 2026 Jan 14;11(1):50. doi: 10.1038/s41541-026-01370-7.

    PubMed 41535296

  • Kaplonek P, Vargas R, Lee JS, Bertera H, Astley E, Girard B, Oostendorp J, Henry C, Paris R, Yu WH, Alter G. mRNA-1010 influenza vaccine elicits distinct and enhanced humoral immunity compared to adjuvanted inactivated vaccines. NPJ Vaccines. 2025 Dec 15;11(1):19. doi: 10.1038/s41541-025-01340-5.

    PubMed 41398408

  • Fierro C, Sanchez-Crespo N, Makrinos D, Zhang W, Sun Y, Rohilla P, Girard B, Adeniji A, DiPiazza A, Paris R. Shared clinical and immunologic features of mRNA vaccines: preliminary results from a comparative clinical study. Front Immunol. 2025 Apr 10;16:1501275. doi: 10.3389/fimmu.2025.1501275. eCollection 2025.

    PubMed 40276503

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mRNA-1273, mRNA-1010 and mRNA-1345 in people with SARS-CoV-2 and Seasonal Influenza, run by ModernaTX, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) (time frame: Up to Day 176 (7 days follow-up post-vaccination)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05397223, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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