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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Approximately 7 weeks
Participants receive two intramuscular injections of either the mRNA-1018-H5 vaccine or placebo on Day 1 and Day 22.
2 visits (Day 1 and Day 22 injections) and additional safety monitoring visits up to Day 50
Duration - Up to 6 months after last injection
Participants are monitored for safety and immunogenicity outcomes up to Day 205 after the last injection.
Visits at Days 43, 50, and 205 for immunogenicity and safety assessments
Trial Site Locations
Total: 36 locations
1
Velocity Clinical Research, San Bernardino
San Bernardino, California, United States, 92408
Not Yet Recruiting
2
Velocity Clinical Research, Savannah
Savannah, Georgia, United States, 31406
Not Yet Recruiting
3
Velocity Clinical Research, Boise
Meridian, Idaho, United States, 83642
Not Yet Recruiting
4
Velocity Clinical Research, Rockville
Rockville, Maryland, United States, 20854
Not Yet Recruiting
5
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States, 68134
Not Yet Recruiting
6
Velocity Clinical Research, Cleveland
Beachwood, Ohio, United States, 44122
Actively Recruiting
7
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States, 02818
Actively Recruiting
8
Velocity Clinical Research, Anderson
Anderson, South Carolina, United States, 29621
Not Yet Recruiting
9
Velocity Clinical Research, Dallas
Dallas, Texas, United States, 75230
Actively Recruiting
10
Velocity Clinical Research, Suffolk
Suffolk, Virginia, United States, 23435
Not Yet Recruiting
11
Velocity Clinical Research-Bristol
Bristol, Bristol (Unitary Authority), United Kingdom, BS8 2RA
Not Yet Recruiting
12
Velocity Clinical Research - High Wycombe
High Wycombe, Buckinghamshire, United Kingdom, HP11 2QW
Not Yet Recruiting
13
Wansford Research Ltd
Peterborough, Cambridgeshire, United Kingdom, PE8 6PL
Not Yet Recruiting
14
Futuremeds Teesside Middlefield Centre University Hospital of North Tees
Stockton-on-Tees, County Durham, United Kingdom, TS19 8PE
Not Yet Recruiting
15
NIHR Wessex CRDC - Bournemouth Research Hub (Under University Hospital Southampton NHS Foundation Trust)
Bournemouth, Dorset, United Kingdom, BH7 7DW
Not Yet Recruiting
16
NIHR Wessex CRDC - Weymouth Research Hub (Under University Hospital Southampton NHS Foundation Trust)
Weymouth, Dorset, United Kingdom, DT4 0QE
Not Yet Recruiting
17
Panthera Glasgow
Glasgow, Glasgow City (Scotland), United Kingdom, G51 4TF
Not Yet Recruiting
18
Panthera Enfield
Enfield, Greater London, United Kingdom, EN3 4GS
Not Yet Recruiting
19
Hounslow Medical Centre
Hounslow, Greater London, United Kingdom, TW3 3ET
Not Yet Recruiting
20
hVIVO Services Limited
London, Greater London, United Kingdom, E1 1EQ
Not Yet Recruiting
21
Velocity Clinical Research-North London
London, Greater London, United Kingdom, N12 8BU
Not Yet Recruiting
22
Accellacare North London
Northwood, Greater London, United Kingdom, HA6 2RN
Not Yet Recruiting
23
Accellacare South London
Orpington, Greater London, United Kingdom, BR5 3QG
Not Yet Recruiting
24
Velocity Clinical Research-Romford
Romford, Greater London, United Kingdom, RM1 3PJ
Not Yet Recruiting
25
Panthera Rochdale
Rochdale, Greater Manchester, United Kingdom, OL11 4AU
Not Yet Recruiting
26
NIHR Wessex CRDC - Southampton Research Hub (Under University Hospital Southampton NHS FT)
Southampton, Hampshire, United Kingdom, SO15 3UA
Not Yet Recruiting
27
Fylde Coast Clinical Research at Layton Medical Centre
Blackpool, Lancashire, United Kingdom, FY3 7EN
Not Yet Recruiting
28
FutureMeds Liverpool
Metropolitan Borough of Wirral, Merseyside, United Kingdom, CH62 6EE
Not Yet Recruiting
29
Lakeside Healthcare
Corby, North Northamptonshire, United Kingdom, NN17 2UR
Not Yet Recruiting
30
Panthera York
York, North Yorkshire, United Kingdom, YO24 4LJ
Not Yet Recruiting
31
The University of Nottingham Health Service
Nottingham, Nottinghamshire, United Kingdom, NG7 2QW
Not Yet Recruiting
32
Panthera Sheffield
Sheffield, South Yorkshire, United Kingdom, S2 5FX
Not Yet Recruiting
33
FutureMeds Newcastle
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE61SG
Not Yet Recruiting
34
Accellacare Warwickshire
Coventry, West Midlands (Coventry), United Kingdom, CV3 4FJ
Not Yet Recruiting
35
FutureMeds Birmingham Soho Road Health Centre
Birmingham, West Midlands, United Kingdom, B21 9RY
Not Yet Recruiting
36
Accellacare Yorkshire
Shipley, West Yorkshire, United Kingdom, BD18 3SA
Not Yet Recruiting
Research Team
M
Moderna WeCare Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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