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Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults

This study is testing an experimental vaccine called mRNA-1018-H5 to see how well it helps your body create protection against influenza (the flu) and to check for any side effects. Researchers will compare mRNA-1018-H5 to a placebo (an inactive substance, like a sugar pill, given to a control group). You might be able to join if you are a healthy adult, 18 years or older. This study aims to enroll about 4000 participants. The study will measure success by looking at how many participants develop a certain level of protective antibodies (immune proteins) against the flu and by tracking any side effects after receiving the vaccine. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 4000 healthy adults.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures antibody levels at Day 43 and tracks side effects for up to 29 days after each injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07496450

A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults

Active, Not Recruiting
PHASE3Ages 18+InterventionalPrevention
ModernaTX, Inc.
~4,050 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:mRNA-1018-H5Placebo

At a glance

Recruiting sites
0 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43
Measured over Day 43
+4 more outcomes measured

Conditions

Influenza

Explore related trials

Influenza

Where it's being run

35 sites across 28 states
Greater London7
Dorset2
California1
Georgia1
Idaho1
Maryland1
Nebraska1
Ohio1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted.
Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding, and one of the following conditions applies:
Is a person of nonchildbearing potential (PONCBP) OR
Is a person of childbearing potential (POCBP)
A POCBP must have a negative highly sensitive pregnancy test at Screening and on the day of the first dose of study intervention.

Exclusion

Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) within 72 hours prior to or at the Screening Visit or Day 1.
History of myocarditis, pericarditis, or myopericarditis.
History of Guillain-Barre syndrome.
Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
Treated with antiviral therapies for influenza (eg, Tamiflu, Xofluza) within 28 days prior to Day 1.
Prior receipt of a pandemic influenza vaccine or participation in any pandemic influenza vaccine clinical study, including the mRNA-1018-P101 study.
Any medical, psychiatric, or occupational condition, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with adherence to study procedures or the interpretation of study results.
Participant has received systemic immunosuppressants including long-acting biological therapies that affect immune responses (eg, infliximab, methotrexate, omalizumab, etc.), within 180 days prior to Screening or plans to do so at any time during participation in the study.
Participant has received corticosteroids at ≥10 mg/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
Participants has received any licensed vaccine authorized or approved by local health agency including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 21 days after the study intervention.
Participant has participated in an interventional clinical study within 90 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.

What this trial measures

  • Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43Day 43

    HAI Titer \>=1:40.

  • Percentage of Participants With Seroconversion at Day 43, as Measured by HAI AssayDay 43

    Seroconversion is defined as a Day 43 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in HAI titer measured by HAI assay.

  • Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)Up to Day 29 (7 days after each injection)
  • Number of Participants with Unsolicited Adverse Events (AEs)Up to Day 50 (28 days after each injection)
  • Number of Participants with AEs Leading to Discontinuation, Medically-attended AEs (MAAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)Day 1 to Day 205