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Seasonal InfluenzaPhase 1/2NCT05827068

A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults

A Phase 1/2 study testing mRNA-1011.1, mRNA-1011.2 and mRNA-1012.1 in people with Seasonal Influenza, run by ModernaTX, Inc. at 22 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 purpose of this study is to measure the safety and the immune response to 3 next-generation influenza vaccine candidates (mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1) compared with influenza vaccine candidate mRNA-1010 controls in healthy adult participants. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Seasonal Influenza
What is being tested?
mRNA-1011.1, mRNA-1011.2 and mRNA-1012.1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
698 participants
Where
22 sitesUnited States
Study dates
27 Mar 2023to 20 Nov 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Body mass index of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the Screening Visit.
  • For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding.

Who cannot join

  • Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
  • 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.
  • Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to the Randomization Visit (for glucocorticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) 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.
  • Participant has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤28 days prior to the study injection (Day 1) or plans to receive a licensed or authorized vaccine within 28 days after the study injection.
  • Participant has received a seasonal influenza vaccine or any other influenza vaccine within 180 days prior to the Randomization Visit.
  • Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to the Randomization Visit.
Show all 9Show fewer
  • Participant has had close contact to someone with or been diagnosed themselves with respiratory syncytial virus or SARS-CoV-2 infection as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to the Randomization Visit.
  • Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Randomization Visit or plans to donate blood products during the study.
  • Note: Other inclusion/exclusion criteria may apply.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • The Corvallis Clinic, PC

    Corvallis, Oregon, 97330

  • Tekton Research

    Edmond, Oklahoma, 73013

  • Tekton Research

    Fort Collins, Colorado, 80528

  • CenExel CBH

    Gaithersburg, Maryland, 20877

  • Hatboro Medical Associates / CCT Research

    Hatboro, Pennsylvania, 19040

  • CenExel RCA

    Hollywood, Florida, 33024

  • Long Beach Research Institute

    Lakewood, California, 90805

  • Critical Care, Pulmonary and Sleep Associates / CCT Research

    Lakewood, Colorado, 80228

  • Healor Primary Care

    Las Vegas, Nevada, 89102

  • Long Beach Clinical Trials

    Long Beach, California, 90806

  • Suncoast Research Associates, LLC

    Miami, Florida, 33173

  • Tekton Research

    Moore, Oklahoma, 73160

  • Trial Management Associates, LLC

    Myrtle Beach, South Carolina, 29572

  • Georgia Clinic / CCT Research

    Norcross, Georgia, 30092

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • DelRicht Research

    Rockville, Maryland, 20852

  • DelRicht Research

    Springfield, Missouri, 65807

  • Springville Dermatology / CCT Research

    Springville, Utah, 84663

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • CenExel FCR

    Tampa, Florida, 33613

  • DelRicht Research

    Town and Country, Missouri, 63017

  • Meridian Clinical Research, LLC

    Vestal, New York, 13850

Other trials in United States

About this study

Official title: A Phase 1/2, Randomized, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults 50 to 75 Years of Age

The purpose of this study is to measure the safety and the immune response to 3 next-generation influenza vaccine candidates (mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1) compared with influenza vaccine candidate mRNA-1010 controls in healthy adult participants.

Being tested
mRNA-1011.1, mRNA-1011.2, mRNA-1012.1, mRNA-1010, mRNA-1010.2
Keywords
Influenza vaccine, mRNA-1010, mRNA-1011.1, mRNA-1011.2, mRNA-1012.1, 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-1011.1Biological

    Also called Seasonal influenza vaccine

    Sterile liquid for injection

  • mRNA-1011.2Biological

    Also called Seasonal influenza vaccine

    Sterile liquid for injection

  • mRNA-1012.1Biological

    Also called Seasonal influenza vaccine

    Sterile liquid for injection

  • mRNA-1010Biological

    Also called Seasonal influenza vaccine

    Sterile liquid for injection

  • mRNA-1010.2Biological

    Also called Seasonal influenza vaccine

    Sterile liquid for injection

  • mRNA-1010.3Biological

    Also called Seasonal influenza vaccine

    Sterile liquid for injection

Study groups in NCT05827068
Study groupRoleWhat they receive
mRNA-1011.1ExperimentalParticipants will receive mRNA-1011.1 by intramuscular (IM) injection on Day 1.
Receives: Biological: mRNA-1011.1
mRNA-1011.2ExperimentalParticipants will receive mRNA-1011.2 by IM injection on Day 1.
Receives: Biological: mRNA-1011.2
mRNA-1012.1 Dose Level AExperimentalParticipants will receive mRNA-1012.1 at dose level A by IM injection on Day 1.
Receives: Biological: mRNA-1012.1
mRNA-1012.1 Dose Level BExperimentalParticipants will receive mRNA-1012.1 at dose level B by IM injection on Day 1.
Receives: Biological: mRNA-1012.1
mRNA-1010Active comparatorParticipants will receive mRNA-1010 by IM injection on Day 1.
Receives: Biological: mRNA-1010
mRNA-1010.2Active comparatorParticipants will receive mRNA-1010.2 by IM injection on Day 1.
Receives: Biological: mRNA-1010.2
mRNA-1010.3Active comparatorParticipants will receive mRNA-1010.3 by IM injection on Day 1.
Receives: Biological: mRNA-1010.3

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 Adverse Reactions (ARs)

    Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity.

    Measured: 7 days post-vaccination

  2. Number of Participants With Unsolicited AEs

    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.

    Measured: Up to 28 days post-vaccination

  3. Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation

    An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up) and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 181) are reported in this outcome measure.

    Measured: Day 1 to Day 181 (end of study [EOS])

Secondary outcomes (3)

  1. Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains

    Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.

    Measured: Day 29

  2. Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

    The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% confidence interval (CI) for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.

    Measured: Baseline, Day 29

  3. Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

    Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.

    Seroconversion was defined as a postbaseline titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.

    Measured: Day 29

Timeline

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

  1. First posted24 Apr 2023
  2. Study start27 Mar 2023
  3. Primary completion20 Nov 2023
  4. Study completion20 Nov 2023

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
698 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05827068
Sponsor's protocol ID
mRNA-1011-P101
Status last verified
Jan 2025
First submitted
12 Apr 2023
Last updated
3 Feb 2025
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hsu D, Jayaraman A, Pucci A, Joshi R, Mancini K, Chen HL, Koslovsky K, Mao X, Choi A, Henry C, Vakil J, Stadlbauer D, Jorquera P, Arunkumar GA, Sanchez-Crespo NE, Wadsworth LT, Bhupathy V, Du E, Avanesov A, Ananworanich J, Nachbagauer R. Safety and immunogenicity of mRNA-based seasonal influenza vaccines formulated to include multiple A/H3N2 strains with or without the B/Yamagata strain in US adults aged 50-75 years: a phase 1/2, open-label, randomised trial. Lancet Infect Dis. 2025 Jan;25(1):25-35. doi: 10.1016/S1473-3099(24)00493-6. Epub 2024 Sep 5.

    PubMed 39245055

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing mRNA-1011.1, mRNA-1011.2 and mRNA-1012.1 in people with Seasonal Influenza, run by ModernaTX, Inc. at 22 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 9 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Adverse Reactions (ARs) (time frame: 7 days post-vaccination). The study lists 3 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 NCT05827068, which also lists 1 linked publication.

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 3 Feb 2025.

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