AzTrials
AzTrials

InfluenzaPhase 2NCT05606965

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults

A Phase 2 study testing mRNA-1010, Egg-based Quadrivalent Influenza Vaccine and Adjuvanted Quadrivalent Influenza Vaccine in people with Influenza, run by ModernaTX, Inc. at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
mRNA-1010, Egg-based Quadrivalent Influenza Vaccine and Adjuvanted Quadrivalent Influenza Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteUnited States
Study dates
2 Nov 2022to 13 Nov 2025
Phase
Phase 2
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults 18-50 years (Study Parts A, B, and C) and 65-80 years (Study Parts A and B only) of age at the time of consent (Screening Visit).
  • Part A only: Body mass index (BMI) of 18 kilograms (kg)/meter (m)^2 to < 40 kg/m^2 at the Screening Visit. There will be no BMI requirement for inclusion in Part B and Part C.
  • A person of childbearing potential (POCBP): has a negative highly sensitive pregnancy test at the Screening Visit and before each administration of study intervention; must use a contraceptive method that is highly effective from at least 28 days prior to Day 1 (Baseline) to at least 3 months after the last study intervention; and is not currently pregnant or breastfeeding.

Who cannot join

  • Acutely ill or febrile (temperature ≥ 38.0°Celsius (C)/100.4° Fahrenheit (F) hours before or at the D1 vaccination visit. Participants meeting this criterion may be rescheduled within the 28-day screening window.
  • Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
  • Reported history of congenital or acquired immunodeficiency, immunocompromizing or immunosuppressive condition, asplenia, or history of recurrent severe infections. Certain immune-mediated conditions that are stable and well-controlled (for example, Hashimoto's thyroid disease) or that do not require systemic immunosuppressive therapy may be permitted at the discretion of the Investigator.
  • Dermatologic conditions that could affect local solicited AR assessments (tattoos, psoriatic patches or vitiligo affecting skin over the deltoid injection site area).
  • Has received systemic immunosuppressants (for glucocorticoids ≥ 10 mg/day of prednisone or equivalent) for > 14 days in total within 180 days before vaccination visit (D1) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
  • Has received systemic immunoglobulins or long-acting biological therapies that may suppress or alter immune responses (for example, Infliximab®) or blood products within 90 days before the vaccination visit or plans to receive them during the study.
  • Has a history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.
  • Other protocol-defined inclusion/exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University in St. Louis

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Phase 2, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 and Comparator Seasonal Influenza Vaccines in Healthy Adults

The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.

Read the detailed description

The study consists of 3 parts. Part A of the study was conducted for the 2022-23 influenza season. Part B of the study was conducted in 2023-24 influenza season. Part C of the study will be conducted in 2024-25 influenza season.

Conditions
Influenza
Being tested
mRNA-1010, Egg-based Quadrivalent Influenza Vaccine, Adjuvanted Quadrivalent Influenza Vaccine, Inactivated Influenza Vaccine, mRNA-1345
Keywords
mRNA-1010, Influenza Vaccine, Moderna
Medical subject headings
Influenza, Human

What participants receive

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

  • mRNA-1010Biological

    Sterile liquid for injection

  • Egg-based Quadrivalent Influenza VaccineBiological

    Also called Fluarix®

    Sterile suspension for injection

  • Adjuvanted Quadrivalent Influenza VaccineBiological

    Also called Fluad®

    Sterile injectable emulsion

  • Inactivated Influenza VaccineBiological

    Also called Fluzone®

    Sterile suspension for injection

  • mRNA-1345Biological

    Sterile liquid for injection

  • mRNA-1045Biological

    Sterile liquid for injection

Study groups in NCT05606965
Study groupRoleWhat they receive
Parts A and B - Arm 1: mRNA-1010 (Age Group 18-50 years)ExperimentalParticipants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Receives: Biological: mRNA-1010
Parts A and B - Arm 2: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)Active comparatorParticipants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1.
Receives: Biological: Egg-based Quadrivalent Influenza Vaccine
Parts A and B - Arm 3: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)Active comparatorParticipants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.
Receives: Biological: Adjuvanted Quadrivalent Influenza Vaccine
Parts A and B - Arm 4: Inactivated Influenza Vaccine (Age Group 65-80 years)Active comparatorParticipants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1.
Receives: Biological: Inactivated Influenza Vaccine
Parts A and B - Arm 5: mRNA-1010 (Age Group 65-80 years)ExperimentalParticipants will receive a single dose of mRNA-1010 by IM injection on Day 1.
Receives: Biological: mRNA-1010
Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)ExperimentalParticipants will receive one dose of mRNA-1010 concomitantly injected with one dose of mRNA-1345 in the contralateral arm at Day 1.
Receives: Biological: mRNA-1010; Biological: mRNA-1345
Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)ExperimentalParticipants will receive one dose of mRNA-1010 at Day 1 followed by one dose of mRNA-1345 in the contralateral arm at Day 29.
Receives: Biological: mRNA-1010; Biological: mRNA-1345
Part C - Arm 3: mRNA-1045 (Age Group 18-50 years)ExperimentalParticipants will receive a single dose of mRNA-1045 by IM injection on Day 1.
Receives: Biological: mRNA-1045

What is being measured

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

  1. Parts A, B, and C: Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

    Measured: Up to Day 7 (7 days after vaccination)

  2. Parts A, B, and C: Number of Unsolicited Adverse Events (AEs)

    Measured: Up to Day 28 (28 days after vaccination)

  3. Parts A, B, and C: Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation

    Measured: Day 1 through Day 181

  4. Parts A, B, and C: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay

    Measured: Day 29

  5. Part C: GMT of Anti-Respiratory Syncytial Virus (RSV) Antibodies at Day 29, as Measured by Microneutralization Assay for RSV A and B

    Measured: Day 29

  6. Parts A, B, and C: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay

    Measured: Baseline, Day 29

  7. Part C: GMFR of Anti-RSV Antibodies at Day 29, as Measured by Microneutralization Assay

    Measured: Baseline, Day 29

  8. Parts A, B, and C: Percentage of Participants with Seroresponse at Day 29, as Measured by HAI Assay

    Seroresponse is defined as a Day 29 titer > 1:40 if baseline is < 1:10 or a minimum 4-fold rise if baseline is >1:10 in anti-HA antibodies measured by HAI assay.

    Measured: Day 29

  9. Part C: Percentage of Participants with Seroresponse at Day 29, as Measured by RSV Neutralization Assay

    Seroresponse is defined as post-baseline titer ≥4-fold if baseline is ≥LLOQ or ≥4×LLOQ if baseline titer is <LLOQ in neutralizing antibody titers measured by RSV neutralization assay, at Day 29.

    Measured: Day 29

Secondary outcomes (6)

  1. Parts A and B: GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization Assay

    Measured: Days 121 and 181

  2. Part C: GMT of Anti-HA Antibodies at Days 57, 121, and 181, as Measured by HAI Assay or Microneutralization Assay

    Measured: Days 57, 121, and 181

  3. Parts A and B: GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay

    Measured: Baseline, Days 121 and 181

  4. Part C: GMFR of Anti-HA Antibodies at Days 57, 121, and 181, as Measured by HAI Assay or MN Assay

    Measured: Baseline, Days 57, 121, and 181

  5. Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by HAI Assay

    Seroresponse is defined as a Day 57, 121, or 181 titer > 1:40 if baseline is < 1:10 or a minimum 4-fold rise if baseline is >1:10 in anti-HA antibodies measured by HAI assay.

    Measured: Days 57, 121, and 181

  6. Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by RSV Neutralization Assay

    Seroresponse is defined as post-baseline titer ≥4-fold if baseline is ≥LLOQ or ≥4×LLOQ if baseline titer is <LLOQ in neutralizing antibody titers measured by RSV neutralization assay, at Days 57, 121, or 181.

    Measured: Days 57, 121, and 181

Timeline

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

  1. First posted7 Nov 2022
  2. Study start2 Nov 2022
  3. Primary completion13 Nov 2025
  4. Study completion13 Nov 2025

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study design for Part A and Prt C is randomized and Part B is non-randomized.
Masking
None (open label)
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05606965
Sponsor's protocol ID
mRNA-CRID-003
Status last verified
Nov 2025
First submitted
31 Oct 2022
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mRNA-1010, Egg-based Quadrivalent Influenza Vaccine and Adjuvanted Quadrivalent Influenza Vaccine in people with Influenza, run by ModernaTX, Inc. at 1 site 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 3 inclusion and 8 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Parts A, B, and C: Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) (time frame: Up to Day 7 (7 days after vaccination)). The study lists 9 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 NCT05606965.

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 24 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in