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Purpose

The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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 Criteria

  • 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. Note: Other inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
mRNA-1018-H5 Vaccine 		Participants will receive mRNA-1018-H5 vaccine by intramuscular (IM) injection on Day 1 and Day 22.
  • Biological: mRNA-1018-H5
    Sterile liquid for injection.
Placebo Comparator
Placebo 		Participants will receive placebo matched to mRNA-1018-H5 vaccine by IM injection on Day 1 and Day 22.
  • Biological: Placebo
    Sterile liquid for injection.

Recruiting Locations

Velocity Clinical Research, San Bernardino
San Bernardino, California 92408

Velocity Clinical Research, Savannah
Savannah, Georgia 31406

Velocity Clinical Research, Boise
Meridian, Idaho 83642

Velocity Clinical Research, Rockville
Rockville, Maryland 20854

Velocity Clinical Research, Omaha
Omaha, Nebraska 68134

Velocity Clinical Research, Cleveland
Beachwood, Ohio 44122

Velocity Clinical Research, Providence
East Greenwich, Rhode Island 02818

Velocity Clinical Research, Anderson
Anderson, South Carolina 29621

Velocity Clinical Research, Dallas
Dallas, Texas 75230

Velocity Clinical Research, Suffolk
Suffolk, Virginia 23435

More Details

Status
Recruiting
Sponsor
ModernaTX, Inc.

Study Contact

Moderna WeCare Team
1-866-663-3762
WeCareClinicalTrials@modernatx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.