InfluenzaPhase 1/2NCT05972174
A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults
A Phase 1/2 study testing mRNA-1018 for H5N8, mRNA-1018 for H7N9 and mRNA-1018 for H5 Only in people with Influenza, run by ModernaTX, Inc. at 27 sites in 2 countries.
Trial summary
The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. 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 for H5N8, mRNA-1018 for H7N9 and mRNA-1018 for H5 Only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,504 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 10 Jul 2023to 16 Jul 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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, physical examination, laboratory tests, and results of electrocardiogram testing.
- Body mass index of 18 kilograms (kg)/square meter (m^2) to 39 kg/m^2 (inclusive) at the Screening visit.
- For female participants of childbearing potential: negative pregnancy test, adequate contraception, and not currently breastfeeding.
Who cannot join
- Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- Participant has received any 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 28 days before or after the study intervention.
- Participant has participated in an interventional clinical study within 28 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.
- Other inclusion/exclusion criteria may apply.
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United Kingdom18 sites
University Hospitals Birmingham
Birmingham, London, B15 2TH
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, London, BD9 6RL
University Hospitals
Bristol, London, Bs2 8DX
Cardiff and Vale University
Cardiff, London, CF14 4XW
Lakeside Healthcare Research Unit
Corby, Northamptonshire, NN17 2UR
Western Hospital Edinburgh
Edinburgh, EH4 CXU
Royal Free Hospital
London, NW3 2QG
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, SE1 7EH
Chelsea and Westminster Hospital
London, SW10 9NH
St Georges Vaccine Institute Cranmer Terrace
London, SW17 ORE
University College London Hospitals NHS Foundation Trust
London, W1T 7HA
Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
Velocity Clinical Research
North Finchley, N12 8BU
Quadram Institute NNUH CRF
Norwich, Norfolk, NR4 7UQ
Northern Care Alliance
Salford, London, M6 8HD
Southampton General Hospital
Southampton, England, SO16 6YD
Royal Cornwall Hospital
Truro, London, TR1 3LJ
North Wales Clinical Research Centre
Wrexham, London, LL13 7YP
United States9 sites
Velocity Clinical Research Providence
East Greenwich, Rhode Island, 02818
CenExel RCA
Hollywood, Florida, 33024
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Velocity Clinical Research
Lincoln, Nebraska, 68510
Velocity Clinical Research
Savannah, Georgia, 31406
J. Lewis Research, Inc/Jordan River Family Medicine
South Jordan, Utah, 84095
DM Clinical Research
Southfield, Michigan, 48076
DM Clinical Research
Sugar Land, Texas, 77478
DM Clinical Research
Tomball, Texas, 77375
About this study
Official title: Phase 1/2, Randomized, Observer-Blind, Parallel, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults ≥18 Years of Age
The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG).
- Conditions
- Influenza
- Being tested
- mRNA-1018 for H5N8, mRNA-1018 for H7N9, mRNA-1018 for H5 Only, mRNA-1018 for H7 Only, mRNA-1018 for H5 Only-CG
- Keywords
- Influenza vaccine, Moderna, mRNA-1018, Virus Diseases, Vaccines, Pandemic influenza
- Medical subject headings
- Influenza, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1018 for H5N8Biological
Sterile liquid for injection
mRNA-1018 for H7N9Biological
Sterile liquid for injection
mRNA-1018 for H5 OnlyBiological
Sterile liquid for injection
mRNA-1018 for H7 OnlyBiological
Sterile liquid for injection
mRNA-1018 for H5 Only-CGBiological
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1 | Experimental | Participants will receive mRNA-1018 for H5N8 at dose level 1 by intramuscular (IM) injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H5N8 |
| Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2 | Experimental | Participants will receive mRNA-1018 for H5N8 at dose level 2 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H5N8 |
| Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3 | Experimental | Participants will receive mRNA-1018 for H5N8 at dose level 3 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H5N8 |
| Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1 | Experimental | Participants will receive mRNA-1018 for H5 only at dose level 1 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H5 Only |
| Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2 | Experimental | Participants will receive mRNA-1018 for H5 only at dose level 2 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H5 Only |
| Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3 | Experimental | Participants will receive mRNA-1018 for H5 only at dose level 3 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H5 Only |
| Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1 | Experimental | Participants will receive mRNA-1018 for H7N9 at dose level 1 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H7N9 |
| Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2 | Experimental | Participants will receive mRNA-1018 for H7N9 at dose level 2 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H7N9 |
| Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3 | Experimental | Participants will receive mRNA-1018 for H7N9 at dose level 3 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H7N9 |
| Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1 | Experimental | Participants will receive mRNA-1018 for H7 only at dose level 1 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H7 Only |
| Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2 | Experimental | Participants will receive mRNA-1018 for H7 only at dose level 2 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H7 Only |
| Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3 | Experimental | Participants will receive mRNA-1018 for H7 only at dose level 3 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H7 Only |
| Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1 | Experimental | Participants will receive mRNA-1018 for H5 Only-CG at dose level 1 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H5 Only-CG |
| Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2 | Experimental | Participants will receive mRNA-1018 for H5 Only-CG at dose level 2 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H5 Only-CG |
| Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3 | Experimental | Participants will receive mRNA-1018 for H5 Only-CG at dose level 3 by IM injection on Day 1 and Day 22. Receives: Biological: mRNA-1018 for H5 Only-CG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 43 (21 days after each injection)
Number of Participants with AEs Leading to Discontinuation From Study
Measured: Day 1 to Day 205 (end of study [EoS])
Number of Participants with Medically-Attended AEs (MAAEs)
Measured: Day 1 to Day 205 (EoS)
Number of Participants with Serious Adverse Events (SAEs)
Measured: Day 1 to Day 205 (EoS)
Number of Participants with Adverse Events of Special Interest (AESIs)
Measured: Day 1 to Day 205 (EoS)
Secondary outcomes (7)
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay
Measured: Days 22, 29, and 43
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay
Measured: Baseline (Day 1), Days 22, 29, and 43
Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay
Seroconversion is defined as a Day 22, 29, or 43 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
Measured: Baseline (Day 1) to Days 22, 29, and 43
Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43
Measured: Days 22, 29, and 43
GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay
Measured: Days 22, 29, and 43
GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay
Measured: Baseline (Day 1), Days 22, 29, and 43
Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise
Number of participants with a change in the Days 22, 29, or 43 NAI titer of at least 2-/3-/4-fold rise, defined as ≥2-/3-/4-fold of the lower level of quantitation (LLOQ) if the Day 1 titer is <LLOQ; or ≥2-/3-/4-fold of the Day 1 titer if the Day 1 titer is ≥LLOQ.
Measured: Baseline (Day 1) to Days 22, 29, and 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start10 Jul 2023
- Primary completion16 Jul 2024
- Study completion16 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,504 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
- NCT05972174
- Sponsor's protocol ID
- mRNA-1018-P101
- Status last verified
- Jun 2025
- First submitted
- 25 Jul 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cosgrove CA, Avanesov A, Rust D, Osibajo S, Kang K, Leav B; ODYSSEY Study Group. A Phase 1/2 Dose-Ranging Safety and Immunogenicity Study of mRNA-Based Candidate Pandemic Influenza Vaccines in Healthy Adults. Clin Infect Dis. 2026 Oct 7;83(3):e598-e610. doi: 10.1093/cid/ciag278.
PubMed 42033146
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2, Randomized, Observer-Blind, Parallel, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults ≥18 Years of Age
- ClinicalTrials.gov ID
- NCT05972174
- Acronym / sponsor ID
- mRNA-1018-P101
- Conditions
- Influenza
- Keywords
- Influenza vaccine, Moderna, mRNA-1018, Virus Diseases, Vaccines, Pandemic influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,504 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 2 Aug 2023 (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 Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1 | Experimental | Biological: mRNA-1018 for H5N8Participants will receive mRNA-1018 for H5N8 at dose level 1 by intramuscular (IM) injection on Day 1 and Day 22. |
| Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2 | Experimental | Biological: mRNA-1018 for H5N8Participants will receive mRNA-1018 for H5N8 at dose level 2 by IM injection on Day 1 and Day 22. |
| Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3 | Experimental | Biological: mRNA-1018 for H5N8Participants will receive mRNA-1018 for H5N8 at dose level 3 by IM injection on Day 1 and Day 22. |
| Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1 | Experimental | Biological: mRNA-1018 for H5 OnlyParticipants will receive mRNA-1018 for H5 only at dose level 1 by IM injection on Day 1 and Day 22. |
| Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2 | Experimental | Biological: mRNA-1018 for H5 OnlyParticipants will receive mRNA-1018 for H5 only at dose level 2 by IM injection on Day 1 and Day 22. |
| Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3 | Experimental | Biological: mRNA-1018 for H5 OnlyParticipants will receive mRNA-1018 for H5 only at dose level 3 by IM injection on Day 1 and Day 22. |
| Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1 | Experimental | Biological: mRNA-1018 for H7N9Participants will receive mRNA-1018 for H7N9 at dose level 1 by IM injection on Day 1 and Day 22. |
| Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2 | Experimental | Biological: mRNA-1018 for H7N9Participants will receive mRNA-1018 for H7N9 at dose level 2 by IM injection on Day 1 and Day 22. |
| Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3 | Experimental | Biological: mRNA-1018 for H7N9Participants will receive mRNA-1018 for H7N9 at dose level 3 by IM injection on Day 1 and Day 22. |
| Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1 | Experimental | Biological: mRNA-1018 for H7 OnlyParticipants will receive mRNA-1018 for H7 only at dose level 1 by IM injection on Day 1 and Day 22. |
| Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2 | Experimental | Biological: mRNA-1018 for H7 OnlyParticipants will receive mRNA-1018 for H7 only at dose level 2 by IM injection on Day 1 and Day 22. |
| Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3 | Experimental | Biological: mRNA-1018 for H7 OnlyParticipants will receive mRNA-1018 for H7 only at dose level 3 by IM injection on Day 1 and Day 22. |
| Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1 | Experimental | Biological: mRNA-1018 for H5 Only-CGParticipants will receive mRNA-1018 for H5 Only-CG at dose level 1 by IM injection on Day 1 and Day 22. |
| Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2 | Experimental | Biological: mRNA-1018 for H5 Only-CGParticipants will receive mRNA-1018 for H5 Only-CG at dose level 2 by IM injection on Day 1 and Day 22. |
| Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3 | Experimental | Biological: mRNA-1018 for H5 Only-CGParticipants will receive mRNA-1018 for H5 Only-CG at dose level 3 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 (3 listed)
- Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and results of electrocardiogram testing.
- Body mass index of 18 kilograms (kg)/square meter (m^2) to 39 kg/m^2 (inclusive) at the Screening visit.
- For female participants of childbearing potential: negative pregnancy test, adequate contraception, and not currently breastfeeding.
Key exclusion criteria (7 listed)
- Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- Participant has received any 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 28 days before or after the study intervention.
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 for H5N8Sterile liquid for injection | Biological | Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1, Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2, Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3 |
| mRNA-1018 for H7N9Sterile liquid for injection | Biological | Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1, Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2, Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3 |
| mRNA-1018 for H5 OnlySterile liquid for injection | Biological | Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1, Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2, Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3 |
| mRNA-1018 for H7 OnlySterile liquid for injection | Biological | Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1, Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2, Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3 |
| mRNA-1018 for H5 Only-CGSterile liquid for injection | Biological | Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1, Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2, Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3 |
Primary outcome
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 43 (21 days after each injection)
Number of Participants with AEs Leading to Discontinuation From Study
Time frame: Day 1 to Day 205 (end of study [EoS])
Number of Participants with Medically-Attended AEs (MAAEs)
Time frame: Day 1 to Day 205 (EoS)
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 205 (EoS)
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Day 1 to Day 205 (EoS)
7 secondary outcomes
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay
Time frame: Days 22, 29, and 43
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay
Time frame: Baseline (Day 1), Days 22, 29, and 43
Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay
Time frame: Baseline (Day 1) to Days 22, 29, and 43
Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43
Time frame: Days 22, 29, and 43
GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay
Time frame: Days 22, 29, and 43
GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay
Time frame: Baseline (Day 1), Days 22, 29, and 43
Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise
Time frame: Baseline (Day 1) to Days 22, 29, and 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Derived from this study: PubMed 42033146Cosgrove CA, Avanesov A, Rust D, Osibajo S, Kang K, Leav B; ODYSSEY Study Group. A Phase 1/2 Dose-Ranging Safety and Immunogenicity Study of mRNA-Based Candidate Pandemic Influenza Vaccines in Healthy Adults. Clin Infect Dis. 2026 Oct 7;83(3):e598-e610. doi: 10.1093/cid/ciag278.
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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.
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mRNA-1018 for H5N8, mRNA-1018 for H7N9 and mRNA-1018 for H5 Only in people with Influenza, run by ModernaTX, Inc. at 27 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) (time frame: Up to Day 29 (7 days after each injection)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05972174, which also lists 1 linked publication.
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 16 Jul 2025.