Actively Recruiting
A Phase 3, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of mRNA-1018-H5 Pandemic Influenza Vaccine in Adults 18 Years and Older
Led by ModernaTX, Inc. · Updated on 2026-04-03
4000
Participants Needed
36
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the immune response and safety of the mRNA-1018-H5 vaccine against pandemic influenza in healthy adults aged 18 years and older. The study aims to measure how well the vaccine triggers protective antibodies and to monitor any side effects or reactions. This is a phase 3 randomized trial sponsored by ModernaTX, Inc., focusing on adults without significant health issues or with stable chronic conditions. Participants will be randomly assigned to receive either the mRNA-1018-H5 vaccine or a placebo. Both are given as intramuscular injections on Day 1 and Day 22. The vaccine is a sterile liquid designed for injection. The study includes a blinded design to ensure unbiased safety and immunogenicity assessments. Participants may be monitored for up to 205 days to assess antibody levels and adverse events. During the study, participants will have blood tests to measure antibody responses on Days 22, 43, and 205. Researchers will track local and systemic reactions for 7 days after each injection and any adverse events for up to 205 days. The main outcomes include the percentage of participants achieving protective antibody levels, immune response strength, and safety measures. Participants will be involved in regular visits and evaluations throughout the study period.
CONDITIONS
Brief Title
A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 years or older as determined by medical evaluation
- Participants with stable chronic medical conditions are allowed
- Females assigned at birth or those who could become pregnant must not be pregnant or breastfeeding
- Persons of childbearing potential must have a negative pregnancy test at screening and on Day 1
- Persons of nonchildbearing potential are eligible
You will not qualify if you...
- Acutely ill or feverish (temperature ≥ 38.0°C/100.4°F) within 72 hours before screening or Day 1
- History of myocarditis, pericarditis, or myopericarditis
- History of Guillain-Barre syndrome
- History of congenital or acquired immunodeficiency, immunosuppressive conditions, asplenia, or recurrent severe infections
- Use of antiviral therapies for influenza within 28 days before Day 1
- Prior receipt of any pandemic influenza vaccine or participation in related vaccine studies
- Use of systemic immunosuppressants or long-acting biological therapies within 180 days prior to screening
- Use of corticosteroids at ≥10 mg/day prednisone or equivalent for more than 14 days within 90 days before Day 1
- Receipt of any licensed vaccine, including mRNA vaccines, within 28 days prior to Day 1 or planned vaccination within 21 days after study intervention
- Participation in another interventional clinical study within 90 days prior to screening
- Any medical, psychiatric, or occupational condition that may pose additional risk or interfere with study adherence or results
Research Team
M
Moderna WeCare Team
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