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SARS-CoV-2Phase 1NCT05585632

A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1045 (Influenza and Respiratory Syncytial Virus [RSV]) or mRNA-1230 (Influenza, RSV, and Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2]) Vaccine in Adults 50 to 75 Years Old

A Phase 1 study testing mRNA-1010, mRNA-1345 and mRNA-1273.214 in people with SARS-CoV-2 and Influenza, run by ModernaTX, Inc. at 30 sites in 3 countries.

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 primary goal of this study is to evaluate the safety and reactogenicity of multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) vaccines in healthy older participants. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2, Influenza, RSV
What is being tested?
mRNA-1010, mRNA-1345 and mRNA-1273.214
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
392 participants
Where
30 sitesin 3 countries
Study dates
14 Oct 2022to 28 Feb 2024
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 50 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Investigator assessment that participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
  • Body mass index of 18 to 35 kilograms/square meter (kg/m^2) (inclusive) at the Screening Visit(s).
  • 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 or abstinence through 3 months following the vaccination, and not currently breastfeeding.
  • Fully vaccinated for COVID-19 with an approved primary series according to the locally authorized or approved regimen. The most recent COVID-19 vaccine (primary series or booster) must be ≥120 days before (or less per local guidance) Day 1.

Who cannot join

  • Acutely ill or febrile (temperature ≥38.0°Celsius/[100.4°Fahrenheit]) 72 hours before or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window for re-evaluation and will retain their initially assigned participant number.
  • Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol 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.
  • Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months before screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
  • Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days before study injections (Day 1) or within 28 days after the study injection.
  • Received a licensed seasonal influenza vaccine or any other investigational influenza or RSV vaccine within ≤180 days before Day 1.
  • Tested positive for influenza or RSV by local health authority-approved testing methods within ≤180 days before Day 1.
Show all 9Show fewer
  • Significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14 days, as defined by the United States Center for Disease Control (CDC) or the European Centre for Disease Prevention and Control as a high risk (close contact) of a COVID-19 case or known history of SARS-CoV-2 infection within the past 90 days before Day 1.
  • Donated ≥450 mL of blood products within 28 days before the Screening Visit or plans to donate blood products during the study.
  • Note: Other inclusion and exclusion criteria may apply.

Trial locations and contacts

30 sites in 3 countries.

30 sites in 3 countries

United States14 sites

  • Velocity Clinical Research

    Anderson, South Carolina, 29621

  • Atlanta Center for Medical Research - Family Medicine

    Atlanta, Georgia, 30331

  • Centricity Research

    Columbus, Georgia, 31904

  • Cenexel IRA (iResearch Atlanta)

    Decatur, Georgia, 30030

  • Accel Research Sites

    DeLand, Florida, 32720

  • Research Centers of America (cenexel)

    Hollywood, Florida, 33024

  • DM Clinical Research

    Houston, Texas, 77081

  • Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC)

    Morehead City, North Carolina, 28557

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572

  • Optimal Research

    Peoria, Illinois, 61614

  • DM Clinical Research

    Southfield, Michigan, 48076

  • Accel Research Sites

    St. Petersburg, Florida, 33709

  • DM Clinical Research

    Sugar Land, Texas, 77478

  • Trial Management Associates

    Wilmington, North Carolina, 28403

Other trials in United States

United Kingdom9 sites

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ

  • Royal Devon & Exeter Hospital

    Exeter, EX25DW

  • Chelsea and Westminster Hospital

    London, SW10 9NH

  • St George's Healthcare NHS Trust - University of London - Th

    London, SW17 0RE

  • National Hospital for Neurology and Neurosurgery

    London, WC1N 3GB

  • Newcastle University - Institute of Cellular Medicine (ICM)

    Newcastle, England, NE2 4HH

  • Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC) Campus

    Nottingham, Nottinghamshire, NG7 2UH

  • University of Oxford

    Oxford, Oxfordshire, OX3 7LJ

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Australia7 sites

  • Paratus Clinical Research Brisbane

    Albion, Queensland, 4010

  • Paratus Clinical Research Western Sydney

    Blacktown, New South Wales, 2148

  • Emeritus Research

    Camberwell, Victoria, 3124

  • Nucleus Network Brisbane Clinic - Centre For Clinical Studies

    Herston, Queensland, 4006

  • Paratus Clinical Kanwal

    Kanwal, New South Wales, 2259

  • University of the Sunshine Coast

    South Brisbane, Queensland, 4101

  • AusTrials Taringa

    Taringa, Queensland, QLD 4068

Other trials in Australia

About this study

Official title: Phase 1, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Multi-component Vaccines mRNA-1045 (Influenza and RSV) or mRNA-1230 (Influenza, RSV, and SARS-CoV-2) Compared With mRNA-1010 (Influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) Vaccines in Healthy Adults 50-75 Years of Age

The primary goal of this study is to evaluate the safety and reactogenicity of multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) vaccines in healthy older participants.

Being tested
mRNA-1010, mRNA-1345, mRNA-1273.214, mRNA-1045, mRNA-1230
Keywords
mRNA-1230 Vaccine, mRNA-1045 Vaccine, SARS-CoV-2 Vaccine, Influenza Vaccine, RSV Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
Medical subject headings
Influenza, Human, Coronavirus Infections, Virus Diseases, COVID-19

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

  • mRNA-1345Biological

    Sterile liquid for injection

  • mRNA-1273.214Biological

    Sterile liquid for injection

  • mRNA-1045Biological

    Formulation for injection

  • mRNA-1230Biological

    Formulation for injection

Study groups in NCT05585632
Study groupRoleWhat they receive
mRNA-1010ExperimentalParticipants will receive a dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Receives: Biological: mRNA-1010
mRNA-1345ExperimentalParticipants will receive a dose of mRNA-1345 by IM injection on Day 1.
Receives: Biological: mRNA-1345
mRNA-1273.214ExperimentalParticipants will receive a dose of mRNA-1273.214 by IM injection on Day 1.
Receives: Biological: mRNA-1273.214
mRNA-1045 Dose Level AExperimentalParticipants will receive mRNA-1045 at Dose Level A by IM injection on Day 1.
Receives: Biological: mRNA-1045
mRNA-1045 Dose Level BExperimentalParticipants will receive mRNA-1045 at Dose Level B by IM injection on Day 1.
Receives: Biological: mRNA-1045
mRNA-1045 Dose Level CExperimentalParticipants will receive mRNA-1045 at Dose Level C by IM injection on Day 1.
Receives: Biological: mRNA-1045
mRNA-1230 Dose Level AExperimentalParticipants will receive mRNA-1230 at Dose Level A by IM injection on Day 1.
Receives: Biological: mRNA-1230
mRNA-1230 Dose Level BExperimentalParticipants will receive mRNA-1230 at Dose Level B by IM injection on Day 1.
Receives: Biological: mRNA-1230
mRNA-1230 Dose Level CExperimentalParticipants will receive mRNA-1230 at Dose Level C by IM injection on Day 1.
Receives: Biological: mRNA-1230

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)

    Measured: Up to Day 8 (7 days post vaccination)

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

    Measured: Up to Day 29 (28 days post vaccination)

  3. Number of Participants with Medically-Attended AEs (MAAEs)

    Measured: Day 1 through Day 361

  4. Number of Participants with Adverse Events of Special Interest (AESIs)

    Measured: Day 1 through Day 361

  5. Number of Participants with Serious Adverse Events (SAEs)

    Measured: Day 1 through Day 361

  6. Number of Participants with AEs Leading to Discontinuation

    Measured: Day 1 through Day 361

Secondary outcomes (9)

  1. Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29

    Measured: Baseline (Day 1), Day 29

  2. Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) at Day 29

    Measured: Baseline (Day 1), Day 29

  3. Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29

    Measured: Baseline (Day 1), Day 29

  4. Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29

    Measured: Baseline (Day 1), Day 29

  5. Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29

    Measured: Baseline (Day 1), Day 29

  6. Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29

    Measured: Baseline (Day 1), Day 29

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

    Seroconversion is defined as a Day 29 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: Baseline (Day 1) to Day 29

  8. SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay)

    Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4*LLOQ if baseline titer is <LLOQ in nAb titers measured by PsVNA (or binding antibody assay).

    Measured: Baseline (Day 1) to Day 29

  9. RSV: Percentage of Participants with Seroresponse as Measured by RSV Neutralization Assay

    Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥LLOQ or ≥4*LLOQ if baseline titer is <LLOQ in nAb titers measured by RSV neutralization assay.

    Measured: Baseline (Day 1) to 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 posted19 Oct 2022
  2. Study start14 Oct 2022
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05585632
Sponsor's protocol ID
mRNA-1230-P101
Other IDs
2022-002138-15
Status last verified
Mar 2024
First submitted
14 Oct 2022
Last updated
8 Mar 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mRNA-1010, mRNA-1345 and mRNA-1273.214 in people with SARS-CoV-2 and Influenza, run by ModernaTX, Inc. at 30 sites in 3 countries.

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 4 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 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, United Kingdom, Australia. 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 Adverse Reactions (ARs) (time frame: Up to Day 8 (7 days post vaccination)). The study lists 6 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 NCT05585632.

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 8 Mar 2024.

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