InfluenzaPhase 2NCT05868382
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults
A Phase 2 study testing mRNA-1010, mRNA-1010.4 and mRNA-1010.6 in people with Influenza, run by ModernaTX, Inc. at 10 sites in United States.
Trial summary
The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- mRNA-1010, mRNA-1010.4 and mRNA-1010.6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 May 2023to 19 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow up, including all procedures.
- For assigned females at birth and of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.
Who cannot join
- Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1.
- Participant is acutely ill or febrile (temperature ≥38.0℃elcius [100.4°Fahrenheit]) 72 hours prior to or at the Screening visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window.
- Participant has a 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.
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
- Participant has tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1.
- Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein.
Show all 12Show fewer
- Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal and topical steroids are allowed. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing.
- Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing.
- Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) prior to Day 1.
- Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1.
- Participant is not aware whether they have received an influenza vaccine in the prior 12 months.
- Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
United Medical Associates
Binghamton, New York, 13905
Meridian Clinical Research
Hastings, Nebraska, 68901
CenExel RCA
Hollywood, Florida, 33024
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Meridian Clinical Research
Lincoln, Nebraska, 68510
Suncoast Research Group
Miami, Florida, 33135
Rockville Internal Medicine
Rockville, Maryland, 20854
DM Clinical Research
Southfield, Michigan, 48076
DM Clinical Research
Sugar Land, Texas, 77478
Texas Center for Drug Development
Tomball, Texas, 77375
About this study
Official title: A Phase 2, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults 18 to 49 Years of Age
The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations.
- Conditions
- Influenza
- Being tested
- mRNA-1010, mRNA-1010.4, mRNA-1010.6
- Keywords
- mRNA-1010, Influenza Vaccine, Moderna
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1010Biological
Sterile liquid for injection
mRNA-1010.4Biological
Sterile liquid for injection
mRNA-1010.6Biological
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1010 Dose C | Experimental | Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1. Receives: Biological: mRNA-1010 |
| mRNA-1010.4 Dose B | Experimental | Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1. Receives: Biological: mRNA-1010.4 |
| mRNA-1010.4 Dose C | Experimental | Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1. Receives: Biological: mRNA-1010.4 |
| mRNA-1010.6 Dose A | Experimental | Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1. Receives: Biological: mRNA-1010.6 |
| mRNA-1010.6 Dose B | Experimental | Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1. Receives: Biological: mRNA-1010.6 |
| mRNA-1010.6 Dose C | Experimental | Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1. Receives: Biological: mRNA-1010.6 |
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)
Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Measured: 7 days post-vaccination
Number of Participants With Unsolicited Adverse Events (AEs)
An unsolicited AE was an AE that was not solicited using a participant diary and that was communicated by a participant who has signed the informed consent. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.
Measured: Up to 28 days post-vaccination
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 [COVID-19] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 181) are reported in this outcome measure.
Measured: Day 1 to Day 181 (end of study [EOS])
Secondary outcomes (3)
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation.
Measured: Days 1 (Baseline), 8, 29, 91, and 181
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% confidence interval (CI) for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Measured: Baseline, Days 8, 29, 91, and 181
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroresponse was defined as (a) a post-vaccination antibody titer ≥ 4 * lower limit of quantification (LLOQ) if baseline (Day 1) antibody titer was < LLOQ or (b) a post-vaccination antibody titer ≥ 4-fold of baseline antibody titer if baseline antibody titer was ≥ LLOQ.
Measured: Days 8, 29, 91, and 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start15 May 2023
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 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
- NCT05868382
- Sponsor's protocol ID
- mRNA-CRID-004
- Status last verified
- Nov 2024
- First submitted
- 11 May 2023
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Fierro C, Lin M, Girard B, McGrath S, Chang X, Wu Q, Kuo HH, Harmon C, Oostendorp J. Optimized seasonal influenza mRNA vaccine compositions demonstrate safety and enhanced immunogenicity in a phase 2 study. Hum Vaccin Immunother. 2026 Dec;22(1):2694211. doi: 10.1080/21645515.2026.2694211. Epub 2026 Jul 13.
PubMed 42441816
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults 18 to 49 Years of Age
- ClinicalTrials.gov ID
- NCT05868382
- Acronym / sponsor ID
- mRNA-CRID-004
- Conditions
- Influenza
- Keywords
- mRNA-1010, Influenza Vaccine, Moderna
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Posted 20 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| mRNA-1010 Dose C | Experimental | Biological: mRNA-1010Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1. |
| mRNA-1010.4 Dose B | Experimental | Biological: mRNA-1010.4Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1. |
| mRNA-1010.4 Dose C | Experimental | Biological: mRNA-1010.4Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1. |
| mRNA-1010.6 Dose A | Experimental | Biological: mRNA-1010.6Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1. |
| mRNA-1010.6 Dose B | Experimental | Biological: mRNA-1010.6Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1. |
| mRNA-1010.6 Dose C | Experimental | Biological: mRNA-1010.6Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow up, including all procedures.
- For assigned females at birth and of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.
Key exclusion criteria (12 listed)
- Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1.
- Participant is acutely ill or febrile (temperature ≥38.0℃elcius [100.4°Fahrenheit]) 72 hours prior to or at the Screening visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window.
- Participant has a 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.
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
- Participant has tested positive for influenza by local health authority-approved testing methods within 150 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-1010Sterile liquid for injection | Biological | mRNA-1010 Dose C |
| mRNA-1010.4Sterile liquid for injection | Biological | mRNA-1010.4 Dose B, mRNA-1010.4 Dose C |
| mRNA-1010.6Sterile liquid for injection | Biological | mRNA-1010.6 Dose A, mRNA-1010.6 Dose B, mRNA-1010.6 Dose C |
Primary outcome
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: 7 days post-vaccination
Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Number of Participants With Unsolicited Adverse Events (AEs)
Time frame: Up to 28 days post-vaccination
An unsolicited AE was an AE that was not solicited using a participant diary and that was communicated by a participant who has signed the informed consent. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation
Time frame: Day 1 to Day 181 (end of study [EOS])
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 [COVID-19] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 181) are reported in this outcome measure.
3 secondary outcomes
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Time frame: Days 1 (Baseline), 8, 29, 91, and 181
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Time frame: Baseline, Days 8, 29, 91, and 181
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Time frame: Days 8, 29, 91, and 181
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42441816Fierro C, Lin M, Girard B, McGrath S, Chang X, Wu Q, Kuo HH, Harmon C, Oostendorp J. Optimized seasonal influenza mRNA vaccine compositions demonstrate safety and enhanced immunogenicity in a phase 2 study. Hum Vaccin Immunother. 2026 Dec;22(1):2694211. doi: 10.1080/21645515.2026.2694211. Epub 2026 Jul 13.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mRNA-1010, mRNA-1010.4 and mRNA-1010.6 in people with Influenza, run by ModernaTX, Inc. at 10 sites in United States.
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 2 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: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 7 days post-vaccination). The study lists 3 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 NCT05868382, 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 20 Dec 2024.