Seasonal InfluenzaPhase 1/2NCT04956575
A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults
A Phase 1/2 study testing mRNA-1010 and Active Comparator in people with Seasonal Influenza, run by ModernaTX, Inc. at 21 sites in United States.
Trial summary
The study comprises 3 parts: Phase 1/2, Phase 2 Northern Hemisphere (NH), and Phase 2 extension. The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1010 vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- mRNA-1010 and Active Comparator
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 885 participants
- Where
- 21 sitesUnited States
- Study dates
- 6 Jul 2021to 27 Sep 2022
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase 1/2:
- Participant has a body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the Screening Visit.
- Participant is in good health, in the opinion of the Investigator, based on review of medical history and physical examination performed at screening.
- For female participants 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, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding.
- Phase 2 NH and Phase 2 Extension:
- Participant is medically stable, in the opinion of the Investigator, based on review of medical history and physical examination performed at screening.
- For female participants 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, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding.
Who cannot join
- Phase 1/2:
- Participant has had significant exposure to someone with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, COVID-19, or influenza-like illness (ILI) in the past 14 days prior to the Screening Visit, as defined by the United States Centers for Disease Control and Prevention (CDC) as close contact with someone who has COVID-19.
- Participant has a positive SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) or antigen test in the past 10 days prior to the Screening Visit.
- 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.
- Participant has a pre-existing medical condition that is not stable, at the discretion of the Investigator.
- Participant has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
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- Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months 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 or plans to receive any licensed vaccine ≤28 days prior to the investigational product (IP) injection (Day 1) or plans to receive a licensed vaccine within 28 days after the IP injection, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of type of vaccine) that become available to participants during the study. Efforts should be made to space study vaccination and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.
- Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine after 01 January 2021.
- Phase 2 NH:
- Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the CDC (CDC 2021a) in the past 14 days prior to the Screening Visit, unless the participant has been fully vaccinated for COVID-19.
- Participant is acutely ill or febrile (body temperature ≥ 38.0°C/100.4°F) 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 and will retain their initially assigned participant number.
- Participant has a medical, psychiatric, occupational condition, or history of substance abuse that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
- Participant has a current or previous diagnosis of immunocompromising/immunosuppressive condition, immune mediated disease requiring immune-modifying therapy, asplenia, recurrent severe infections (human immunodeficiency virus [HIV] positive participants on antiretroviral therapy with cluster of differentiation [CD] 4 count ≥ 350 cells/mm3 and HIV RNA ≤ 500 copies/mL within the past 12 months are permitted).
- Participant has received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to Screening Visit (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.
- Participant has a history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or any of the components contained in the mRNA 1010 or the comparator vaccine, which is an egg-based influenza vaccine.
- Participant has received or plans to receive any licensed vaccine ≤ 28 days prior to the IP injection (Day 1) or plans to receive a licensed vaccine within 28 days after the IP injection, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of type of vaccine) that become available to participants during the study. Efforts should be made to space study vaccination and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.
- Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 6 months prior to the Screening Visit.
- Participant has tested positive for influenza by CDC-recommended testing methods within 6 months prior to the Screening Visit.
- 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.
- Phase 2 Extension:
- Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the CDC in the past 10 days prior to the Screening Visit.
- Participant is acutely ill or febrile (body temperature ≥ 38.0°C/100.4°F) 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 and will retain their initially assigned participant number.
- Participant has a medical, psychiatric, occupational condition, or history of substance abuse that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
- Participant has a current or previous diagnosis of immunocompromising/immunosuppressive condition, immune-mediated disease requiring immune-modifying therapy, asplenia, recurrent severe infections (HIV-positive participants on antiretroviral therapy with CD 4 count ≥ 350 cells/mm^3 and HIV-RNA ≤ 500 copies/mL within the past 365 days are permitted).
- Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to Screening Visit (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.
- Participant has a history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or any of the components contained in the mRNA-1010 or the comparator vaccine, which is an egg-based influenza vaccine.
- Participant has received or plans to receive any licensed vaccine ≤ 28 days prior to the IP injection (Day 1) or plans to receive a licensed vaccine within 28 days after the IP injection, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of type of vaccine) that become available to participants during the study. Efforts should be made to space study vaccination and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.
- Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to the randomization visit.
- Participant had tested positive for influenza by CDC-recommended testing methods within 180 days prior to the Screening Visit.
- 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
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Meridian Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809
PanAmerican Clinical Research LLC
Brownsville, Texas, 78520
Meridian Clinical Research - Cincinnati - Platinum - PPDS
Cincinnati, Ohio, 45219
Meridian Clinical Research - Cincinnati - Platinum - PPDS
Cincinnati, Ohio, 45246
Benchmark Research - Colton, CA
Colton, California, 92324
Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
Endwell, New York, 13760
Meridian Clinical Research (Grand Island)
Grand Island, Nebraska, 68803
Keystone VitaLink Research - Greenville - PPDS
Greenville, South Carolina, 29615
Research Centers of America - ERGG - PPDS
Hollywood, Florida, 33024-2709
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Meridian Clinical Research, LLC (Lincoln Nebraska)
Lincoln, Nebraska, 68510
Lucas Research
Morehead City, North Carolina, 28557
Meridian Clinical Research
Omaha, Nebraska, 68134-3664
Cognitive Clinical Trials - Phoenix
Phoenix, Arizona, 85044
Research Your Health - ERN - PPDS
Plano, Texas, 75093
Meridian Clinical Research
Rockville, Maryland, 20854-2957
Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS
Savannah, Georgia, 31406
Meridian Clinical Research
Sioux City, Iowa, 51106-4233
South Ogden Family Medicine/Ogden Clinic - CCT
South Ogden, Utah, 84405
Alliance for Multispecialty Research, LLC - Phoenix
Tempe, Arizona, 85281
Trial Management Associates LLC - ERN - PPDS
Wilmington, North Carolina, 28403
About this study
Official title: A Phase 1/2, Randomized, Stratified, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults 18 Years and Older
The study comprises 3 parts: Phase 1/2, Phase 2 Northern Hemisphere (NH), and Phase 2 extension. The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1010 vaccine.
- Conditions
- Seasonal Influenza
- Being tested
- mRNA-1010, Placebo, Active Comparator
- Keywords
- Influenza vaccine, mRNA-1010, 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
Also called Seasonal influenza vaccine
Sterile liquid for injection
PlaceboBiological
0.9% sodium chloride solution for injection
Active ComparatorBiological
Also called Licensed quadrivalent seasonal influenza
0.5 milliliter (mL) intramuscular (IM) injection
| Study group | Role | What they receive |
|---|---|---|
| Phase 1/2: mRNA-1010 Dose Level A | Experimental | Participants will receive mRNA-1010 at dose level A by intramuscular (IM) injection on Day 1. Receives: Biological: mRNA-1010 |
| Phase 1/2: mRNA-1010 Dose Level B | Experimental | Participants will receive mRNA-1010 at dose level B by IM injection on Day 1. Receives: Biological: mRNA-1010 |
| Phase 1/2: mRNA-1010 Dose Level C | Experimental | Participants will receive mRNA-1010 at dose level C by IM injection on Day 1. Receives: Biological: mRNA-1010 |
| Phase 1/2: Placebo | Experimental | Participants will receive placebo matching to mRNA-1010 by IM injection on Day 1. Receives: Biological: Placebo |
| Phase 2 NH: Active Comparator Dose Level A | Active comparator | Participants will receive active comparator at dose level A by IM injection on Day 1. Receives: Biological: Active Comparator |
| Phase 2 NH: mRNA-1010 Dose Level D | Experimental | Participants will receive mRNA-1010 at dose level D by IM injection on Day 1. Receives: Biological: mRNA-1010 |
| Phase 2 NH: mRNA-1010 Dose Level A | Experimental | Participants will receive mRNA-1010 at dose level A by IM injection on Day 1. Receives: Biological: mRNA-1010 |
| Phase 2 NH: mRNA-1010 Dose Level B | Experimental | Participants will receive mRNA-1010 at dose level B by IM injection on Day 1. Receives: Biological: mRNA-1010 |
| Phase 2 Extension: Active Comparator Dose Level A | Active comparator | Participants will receive active comparator at dose level A by IM injection on Day 1. Receives: Biological: Active Comparator |
| Phase 2 Extension: mRNA-1010 Dose Level D | Experimental | Participants will receive mRNA-1010 at dose level D by IM injection on Day 1. Receives: Biological: mRNA-1010 |
| Phase 2 Extension: mRNA-1010 Dose Level E | Experimental | Participants will receive mRNA-1010 at dose level E by IM injection on Day 1. Receives: Biological: mRNA-1010 |
| Phase 2 Extension: mRNA-1010 Dose Level F | Experimental | Participants will receive mRNA-1010 at dose level F by IM injection on Day 1. Receives: Biological: mRNA-1010 |
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 ARs
Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Solicited ARs (local and systemic) considered causally related to injection were graded 0-4; 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. Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section and presented by Phase/dose group.
Measured: 7 days after vaccination
Number of Participants With Unsolicited AEs
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. 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 worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section and presented by each Phase and dose group separately.
Measured: Up to 28 days after vaccination
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs)
An SAE was defined as any AE that resulted in death, is 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 leads to an unscheduled visit to an healthcare practitioner. This would include visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section and presented by each Phase and dose group separately.
Measured: Up to 6 months (end of study)
Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Measured: Day 29
Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Measured: Day 29
Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Measured: Day 29
Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
Seroconversion at a participant level was defined as (a) if lower limit of quantification (LLOQ) was 1:10, a post-baseline titer ≥1:40 if baseline was <1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was >1:10, a post-baseline titer ≥4 x LLOQ if baseline was <LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies.
Measured: Day 29
Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal 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.
95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
Measured: Day 1 (Baseline), Day 29
Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
Seroconversion at a participant level was defined as (a) if LLOQ was 1:10, a post-baseline titer ≥1:40 if baseline was <1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was >1:10, a post-baseline titer ≥4 x LLOQ if baseline was <LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies.
95% CI was calculated using the Clopper-Pearson method
Measured: Day 29
Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
Seroconversion at a participant level was defined as (a) if LLOQ was 1:10, a post-baseline titer ≥1:40 if baseline was <1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was >1:10, a post-baseline titer ≥4 x LLOQ if baseline was <LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies.
95% CI was calculated using the Clopper-Pearson method
Measured: Day 29
Secondary outcomes (5)
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Measured: Day 1 (Baseline), Day 8 and Day 181
Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal 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.
95% CI was calculated based on the difference in the log-transformed values for GMT, then back transformed to the original scale for presentation.
Measured: Day 1 (Baseline), Day 8 and Day 181
Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
Seroconversion at a participant level was defined as (a) if lower limit of quantification (LLOQ) was 1:10, a post-baseline titer ≥1:40 if baseline was <1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was >1:10, a post-baseline titer ≥4 x LLOQ if baseline was <LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies.
Measured: Day 29
Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal 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.
95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
Measured: Day 29
Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start6 Jul 2021
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
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 (2)Papers the sponsor has linked to this study.
- Other trials for Seasonal 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 885 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
- NCT04956575
- Sponsor's protocol ID
- mRNA-1010-P101
- Status last verified
- Oct 2023
- First submitted
- 30 Jun 2021
- Last updated
- 27 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lee IT, Nachbagauer R, Ensz D, Schwartz H, Carmona L, Schaefers K, Avanesov A, Stadlbauer D, Henry C, Chen R, Huang W, Schrempp DR, Ananworanich J, Paris R. Safety and immunogenicity of a phase 1/2 randomized clinical trial of a quadrivalent, mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults: interim analysis. Nat Commun. 2023 Jun 19;14(1):3631. doi: 10.1038/s41467-023-39376-7.
PubMed 37336877Ananworanich J, Lee IT, Ensz D, Carmona L, Schaefers K, Avanesov A, Stadlbauer D, Choi A, Pucci A, McGrath S, Kuo HH, Henry C, Chen R, Huang W, Nachbagauer R, Paris R. Safety and Immunogenicity of mRNA-1010, an Investigational Seasonal Influenza Vaccine, in Healthy Adults: Final Results From a Phase 1/2 Randomized Trial. J Infect Dis. 2025 Feb 4;231(1):e113-e122. doi: 10.1093/infdis/jiae329.
PubMed 38934845
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Stratified, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults 18 Years and Older
- ClinicalTrials.gov ID
- NCT04956575
- Acronym / sponsor ID
- mRNA-1010-P101
- Conditions
- Seasonal Influenza
- Keywords
- Influenza vaccine, mRNA-1010, Moderna
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 885 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Posted 27 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study comprises 3 parts: Phase 1/2, Phase 2 Northern Hemisphere (NH), and Phase 2 extension. The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1010 vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Phase 1/2: mRNA-1010 Dose Level A | Experimental | Biological: mRNA-1010Participants will receive mRNA-1010 at dose level A by intramuscular (IM) injection on Day 1. |
| Phase 1/2: mRNA-1010 Dose Level B | Experimental | Biological: mRNA-1010Participants will receive mRNA-1010 at dose level B by IM injection on Day 1. |
| Phase 1/2: mRNA-1010 Dose Level C | Experimental | Biological: mRNA-1010Participants will receive mRNA-1010 at dose level C by IM injection on Day 1. |
| Phase 1/2: Placebo | Experimental | Biological: PlaceboParticipants will receive placebo matching to mRNA-1010 by IM injection on Day 1. |
| Phase 2 NH: Active Comparator Dose Level A | Active comparator | Biological: Active ComparatorParticipants will receive active comparator at dose level A by IM injection on Day 1. |
| Phase 2 NH: mRNA-1010 Dose Level D | Experimental | Biological: mRNA-1010Participants will receive mRNA-1010 at dose level D by IM injection on Day 1. |
| Phase 2 NH: mRNA-1010 Dose Level A | Experimental | Biological: mRNA-1010Participants will receive mRNA-1010 at dose level A by IM injection on Day 1. |
| Phase 2 NH: mRNA-1010 Dose Level B | Experimental | Biological: mRNA-1010Participants will receive mRNA-1010 at dose level B by IM injection on Day 1. |
| Phase 2 Extension: Active Comparator Dose Level A | Active comparator | Biological: Active ComparatorParticipants will receive active comparator at dose level A by IM injection on Day 1. |
| Phase 2 Extension: mRNA-1010 Dose Level D | Experimental | Biological: mRNA-1010Participants will receive mRNA-1010 at dose level D by IM injection on Day 1. |
| Phase 2 Extension: mRNA-1010 Dose Level E | Experimental | Biological: mRNA-1010Participants will receive mRNA-1010 at dose level E by IM injection on Day 1. |
| Phase 2 Extension: mRNA-1010 Dose Level F | Experimental | Biological: mRNA-1010Participants will receive mRNA-1010 at dose level F by IM injection on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant has a body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the Screening Visit.
- Participant is in good health, in the opinion of the Investigator, based on review of medical history and physical examination performed at screening.
- For female participants 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, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding.
- Participant is medically stable, in the opinion of the Investigator, based on review of medical history and physical examination performed at screening.
- For female participants 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, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding.
Key exclusion criteria (32 listed)
- Participant has had significant exposure to someone with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, COVID-19, or influenza-like illness (ILI) in the past 14 days prior to the Screening Visit, as defined by the United States Centers for Disease Control and Prevention (CDC) as close contact with someone who has COVID-19.
- Participant has a positive SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) or antigen test in the past 10 days prior to the Screening Visit.
- 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.
- Participant has a pre-existing medical condition that is not stable, at the discretion of the Investigator.
- Participant has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
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-1010Also: Seasonal influenza vaccineSterile liquid for injection | Biological | Phase 1/2: mRNA-1010 Dose Level A, Phase 1/2: mRNA-1010 Dose Level B, Phase 1/2: mRNA-1010 Dose Level C, Phase 2 Extension: mRNA-1010 Dose Level D, Phase 2 Extension: mRNA-1010 Dose Level E, Phase 2 Extension: mRNA-1010 Dose Level F, Phase 2 NH: mRNA-1010 Dose Level A, Phase 2 NH: mRNA-1010 Dose Level B, Phase 2 NH: mRNA-1010 Dose Level D |
| Placebo0.9% sodium chloride solution for injection | Biological | Phase 1/2: Placebo |
| Active ComparatorAlso: Licensed quadrivalent seasonal influenza0.5 milliliter (mL) intramuscular (IM) injection | Biological | Phase 2 Extension: Active Comparator Dose Level A, Phase 2 NH: Active Comparator Dose Level A |
Primary outcome
Number of Participants With Solicited Local and Systemic ARs
Time frame: 7 days after vaccination
Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Solicited ARs (local and systemic) considered causally related to injection were graded 0-4; 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. Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section and presented by Phase/dose group.
Number of Participants With Unsolicited AEs
Time frame: Up to 28 days after vaccination
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. 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 worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section and presented by each Phase and dose group separately.
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs)
Time frame: Up to 6 months (end of study)
An SAE was defined as any AE that resulted in death, is 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 leads to an unscheduled visit to an healthcare practitioner. This would include visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section and presented by each Phase and dose group separately.
Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Time frame: Day 29
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Time frame: Day 29
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Time frame: Day 29
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Time frame: Day 29
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if lower limit of quantification (LLOQ) was 1:10, a post-baseline titer ≥1:40 if baseline was <1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was >1:10, a post-baseline titer ≥4 x LLOQ if baseline was <LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies.
Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Time frame: Day 1 (Baseline), Day 29
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. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Time frame: Day 29
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if LLOQ was 1:10, a post-baseline titer ≥1:40 if baseline was <1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was >1:10, a post-baseline titer ≥4 x LLOQ if baseline was <LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies. 95% CI was calculated using the Clopper-Pearson method
Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Time frame: Day 29
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if LLOQ was 1:10, a post-baseline titer ≥1:40 if baseline was <1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was >1:10, a post-baseline titer ≥4 x LLOQ if baseline was <LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies. 95% CI was calculated using the Clopper-Pearson method
5 secondary outcomes
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Time frame: Day 1 (Baseline), Day 8 and Day 181
Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Time frame: Day 1 (Baseline), Day 8 and Day 181
Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Time frame: Day 29
Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Time frame: Day 29
Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29
Time frame: Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37336877Lee IT, Nachbagauer R, Ensz D, Schwartz H, Carmona L, Schaefers K, Avanesov A, Stadlbauer D, Henry C, Chen R, Huang W, Schrempp DR, Ananworanich J, Paris R. Safety and immunogenicity of a phase 1/2 randomized clinical trial of a quadrivalent, mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults: interim analysis. Nat Commun. 2023 Jun 19;14(1):3631. doi: 10.1038/s41467-023-39376-7.
- Derived from this study: PubMed 38934845Ananworanich J, Lee IT, Ensz D, Carmona L, Schaefers K, Avanesov A, Stadlbauer D, Choi A, Pucci A, McGrath S, Kuo HH, Henry C, Chen R, Huang W, Nachbagauer R, Paris R. Safety and Immunogenicity of mRNA-1010, an Investigational Seasonal Influenza Vaccine, in Healthy Adults: Final Results From a Phase 1/2 Randomized Trial. J Infect Dis. 2025 Feb 4;231(1):e113-e122. doi: 10.1093/infdis/jiae329.
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mRNA-1010 and Active Comparator in people with Seasonal Influenza, run by ModernaTX, Inc. at 21 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 7 inclusion and 32 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 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 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?
Yes. Results are posted in the registry (first posted 27 Oct 2023). 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 ARs (time frame: 7 days after vaccination). The study lists 10 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 NCT04956575, which also lists 2 linked publications.
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 27 Oct 2023.