InfluenzaPhase 3NCT07496450
A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
A Phase 3 study testing mRNA-1018-H5 in people with Influenza, run by ModernaTX, Inc. at 35 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- mRNA-1018-H5
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,050 participants
- Where
- 35 sitesin 2 countries
- Study dates
- 23 Mar 2026to 28 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United Kingdom25 sites
FutureMeds Birmingham Soho Road Health Centre
Birmingham, West Midlands, B21 9RY
Fylde Coast Clinical Research at Layton Medical Centre
Blackpool, Lancashire, FY3 7EN
NIHR Wessex CRDC - Bournemouth Research Hub (Under University Hospital Southampton NHS Foundation Trust)
Bournemouth, Dorset, BH7 7DW
Velocity Clinical Research-Bristol
Bristol, Bristol (Unitary Authority), BS8 2RA
Lakeside Healthcare
Corby, North Northamptonshire, NN17 2UR
Accellacare Warwickshire
Coventry, West Midlands (Coventry), CV3 4FJ
Panthera Enfield
Enfield, Greater London, EN3 4GS
Panthera Glasgow
Glasgow, Glasgow City (Scotland), G51 4TF
Velocity Clinical Research - High Wycombe
High Wycombe, Buckinghamshire, HP11 2QW
Hounslow Medical Centre
Hounslow, Greater London, TW3 3ET
hVIVO Services Limited
London, Greater London, E1 1EQ
Velocity Clinical Research-North London
London, Greater London, N12 8BU
FutureMeds Liverpool
Metropolitan Borough of Wirral, Merseyside, CH62 6EE
Accellacare North London
Northwood, Greater London, HA6 2RN
The University of Nottingham Health Service
Nottingham, Nottinghamshire, NG7 2QW
Accellacare South London
Orpington, Greater London, BR5 3QG
Wansford Research Ltd
Peterborough, Cambridgeshire, PE8 6PL
Panthera Rochdale
Rochdale, Greater Manchester, OL11 4AU
Velocity Clinical Research-Romford
Romford, Greater London, RM1 3PJ
Panthera Sheffield
Sheffield, South Yorkshire, S2 5FX
Accellacare Yorkshire
Shipley, West Yorkshire, BD18 3SA
NIHR Wessex CRDC - Southampton Research Hub (Under University Hospital Southampton NHS FT)
Southampton, Hampshire, SO15 3UA
Futuremeds Teesside Middlefield Centre University Hospital of North Tees
Stockton-on-Tees, County Durham, TS19 8PE
NIHR Wessex CRDC - Weymouth Research Hub (Under University Hospital Southampton NHS Foundation Trust)
Weymouth, Dorset, DT4 0QE
Panthera York
York, North Yorkshire, YO24 4LJ
United States10 sites
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621
Velocity Clinical Research, Cleveland
Beachwood, Ohio, 44122
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818
Velocity Clinical Research, Boise
Meridian, Idaho, 83642
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
Velocity Clinical Research, San Bernardino
San Bernardino, California, 92408
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
Velocity Clinical Research, Suffolk
Suffolk, Virginia, 23435
About this study
Official title: 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 of Age
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.
- Conditions
- Influenza
- Being tested
- mRNA-1018-H5, Placebo
- Keywords
- Influenza Vaccine, Moderna, mRNA-1018-H5, Viral Diseases, Vaccines, Pandemic Influenza, Avian Flu, Bird Flu, Influenza A
- Medical subject headings
- Influenza, Human, Virus Diseases, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1018-H5Biological
Sterile liquid for injection.
PlaceboBiological
Sterile liquid for injection.
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1018-H5 Vaccine | Experimental | Participants will receive mRNA-1018-H5 vaccine by intramuscular (IM) injection on Day 1 and Day 22. Receives: Biological: mRNA-1018-H5 |
| Placebo | Placebo comparator | Participants will receive placebo matched to mRNA-1018-H5 vaccine by IM injection on Day 1 and Day 22. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43
HAI Titer >=1:40.
Measured: Day 43
Percentage of Participants With Seroconversion at Day 43, as Measured by HAI Assay
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.
Measured: Day 43
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Measured: Up to Day 29 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: 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)
Measured: Day 1 to Day 205
Secondary outcomes (4)
Geometric Mean Titer (GMT) of Anti-H5N1 Antibodies at Day 43, as Measured by Microneutralization (MN) Assay
Measured: Day 43
GMT of HAI Antibodies at Days 22 and 205, as Measured by HAI Assay
Measured: Days 22 and 205
GMT of HAI Antibodies at Days 22 and 205, as Measured by MN Assay
Measured: Days 22 and 205
Percentage of Participants with HAI Titers at Different Cut-Offs
Cutoff included >= 1:80.
Measured: Up to Day 205
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start23 Mar 2026
- Primary completion28 Jan 2027 (estimated)
- Study completion28 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496450
- Sponsor's protocol ID
- mRNA-1018-P301
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 of Age
- ClinicalTrials.gov ID
- NCT07496450
- Acronym / sponsor ID
- mRNA-1018-P301
- Conditions
- Influenza
- Keywords
- Influenza Vaccine, Moderna, mRNA-1018-H5, Viral Diseases, Vaccines, Pandemic Influenza, Avian Flu, Bird Flu
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,050 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 28 Jan 2027 (estimated)
- Study completion
- 28 Jan 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mRNA-1018-H5 Vaccine | Experimental | Biological: mRNA-1018-H5Participants will receive mRNA-1018-H5 vaccine by intramuscular (IM) injection on Day 1 and Day 22. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive placebo matched to mRNA-1018-H5 vaccine by IM injection on Day 1 and Day 22. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1018-H5Sterile liquid for injection. | Biological | mRNA-1018-H5 Vaccine |
| PlaceboSterile liquid for injection. | Biological | Placebo |
Primary outcome
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43
Time frame: Day 43
HAI Titer >=1:40.
Percentage of Participants With Seroconversion at Day 43, as Measured by HAI Assay
Time frame: Day 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)
Time frame: Up to Day 29 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: 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)
Time frame: Day 1 to Day 205
4 secondary outcomes
Geometric Mean Titer (GMT) of Anti-H5N1 Antibodies at Day 43, as Measured by Microneutralization (MN) Assay
Time frame: Day 43
GMT of HAI Antibodies at Days 22 and 205, as Measured by HAI Assay
Time frame: Days 22 and 205
GMT of HAI Antibodies at Days 22 and 205, as Measured by MN Assay
Time frame: Days 22 and 205
Percentage of Participants with HAI Titers at Different Cut-Offs
Time frame: Up to Day 205
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mRNA-1018-H5 in people with Influenza, run by ModernaTX, Inc. at 35 sites in 2 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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United Kingdom, United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43 (time frame: Day 43). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.