A Study of mRNA-1010 Seasonal Influenza Vaccine in Health... | NCT04956575 | Trialant
NCT04956575
Sponsor
ModernaTX, Inc.
Status
Completed
Last Update Posted
Oct 27, 2023Actual
Enrollment
885Actual
Phase
Phase 1Phase 2
Conditions
Seasonal Influenza
Interventions
mRNA-1010
Placebo
Active Comparator
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04956575
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
mRNA-1010-P101
Secondary IDs
Not provided
Brief Title
A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults
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
Acronym
Not provided
Organization
ModernaTX, Inc.INDUSTRY
Status Module
Record Verification Date
Oct 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 6, 2021Actual
Primary Completion Date
Sep 27, 2022Actual
Completion Date
Sep 27, 2022Actual
First Submitted Date
Jun 30, 2021
First Submission Date that Met QC Criteria
Jun 30, 2021
First Posted Date
Jul 9, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Sep 25, 2023
Results First Submitted that Met QC Criteria
Oct 25, 2023
Results First Posted Date
Oct 27, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 25, 2023
Last Update Posted Date
Oct 27, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ModernaTX, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
Not provided
Conditions Module
Conditions
Seasonal Influenza
Keywords
Influenza vaccine
mRNA-1010
Moderna
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
885Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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.
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.
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.
Biological: mRNA-1010
Phase 1/2: Placebo
Experimental
Participants will receive placebo matching to mRNA-1010 by IM injection on Day 1.
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.
Biological: Active Comparator
Phase 2 NH: mRNA-1010 Dose Level D
Interventions
Name
Type
Description
Arm Group Labels
Other Names
mRNA-1010
Biological
Sterile liquid for injection
Phase 1/2: mRNA-1010 Dose Level A
Phase 1/2: mRNA-1010 Dose Level B
Phase 1/2: mRNA-1010 Dose Level C
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
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.
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.
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
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.
Key Exclusion Criteria:
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.
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.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Cognitive Clinical Trials - Phoenix
Phoenix
Arizona
85044
United States
Alliance for Multispecialty Research, LLC - Phoenix
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.
For Phase 1/2, 1 participant who was randomly assigned to the 200 micrograms (ug) mRNA-1010 group received a dose of 100 ug and was therefore included in the 100 ug mRNA-1010 group in the Safety Set and the Solicited Safety Set.
For Phase 2 Northern Hemisphere (NH), 1 participant randomly assigned to the 25 ug mRNA-1010 group received 50 ug mRNA-1010, and 1 participant randomly assigned to 50 ug mRNA-1010 received Afluria Quadrivalent.
Recruitment Details
This study was conducted at 20 centers in the United States. The vaccines used in the study were based on the influenza virus strains recommended by the World Health Organization for the southern and northern hemispheres.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1/2: Placebo
Participants received placebo matching to mRNA-1010 by intramuscular (IM) injection on Day 1.
FG001
Phase 1/2: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
Participants will receive mRNA-1010 at dose level D by IM injection on Day 1.
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.
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.
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.
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.
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.
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.
Biological: mRNA-1010
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
Seasonal influenza vaccine
Placebo
Biological
0.9% sodium chloride solution for injection
Phase 1/2: Placebo
Active Comparator
Biological
0.5 milliliter (mL) intramuscular (IM) injection
Phase 2 Extension: Active Comparator Dose Level A
Phase 2 NH: Active Comparator Dose Level A
Licensed quadrivalent seasonal influenza
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.
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.
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.
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 \
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.
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 \
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 \
Day 29
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.
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 \
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.
Day 29
Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29
Day 29
Tempe
Arizona
85281
United States
Benchmark Research - Colton, CA
Colton
California
92324
United States
Research Centers of America - ERGG - PPDS
Hollywood
Florida
33024-2709
United States
Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS
Savannah
Georgia
31406
United States
Meridian Clinical Research
Sioux City
Iowa
51106-4233
United States
Johnson County Clin-Trials
Lenexa
Kansas
66219
United States
Meridian Clinical Research - Baton Rouge
Baton Rouge
Louisiana
70809
United States
Meridian Clinical Research
Rockville
Maryland
20854-2957
United States
Meridian Clinical Research (Grand Island)
Grand Island
Nebraska
68803
United States
Meridian Clinical Research, LLC (Lincoln Nebraska)
Lincoln
Nebraska
68510
United States
Meridian Clinical Research
Omaha
Nebraska
68134-3664
United States
Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
Endwell
New York
13760
United States
Lucas Research
Morehead City
North Carolina
28557
United States
Trial Management Associates LLC - ERN - PPDS
Wilmington
North Carolina
28403
United States
Meridian Clinical Research - Cincinnati - Platinum - PPDS
Cincinnati
Ohio
45219
United States
Meridian Clinical Research - Cincinnati - Platinum - PPDS
Cincinnati
Ohio
45246
United States
Keystone VitaLink Research - Greenville - PPDS
Greenville
South Carolina
29615
United States
PanAmerican Clinical Research LLC
Brownsville
Texas
78520
United States
Research Your Health - ERN - PPDS
Plano
Texas
75093
United States
South Ogden Family Medicine/Ogden Clinic - CCT
South Ogden
Utah
84405
United States
Derived
Ananworanich 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.
FG002
Phase 1/2: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
FG003
Phase 1/2: mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
FG004
Phase 2 NH: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
FG005
Phase 2 NH: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
FG006
Phase 2 NH: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
FG007
Phase 2 NH: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
FG008
Phase 2 Extension: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
FG009
Phase 2 Extension: mRNA-1010 6.25 ug
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
FG010
Phase 2 Extension: mRNA-1010 12.5 ug
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
FG011
Phase 2 Extension: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
FG00045 subjects
FG00145 subjects
FG00245 subjects
FG00345 subjects
FG00453 subjects
FG005153 subjects
FG006149 subjects
FG007148 subjects
FG00851 subjects
FG00950 subjects
FG01051 subjects
FG01150 subjects
Received at Least 1 Dose of Investigational Product
Numbers are based on planned vaccination group.
FG00045 subjects
FG00145 subjects
FG00245 subjects
FG00345 subjects
FG00453 subjects
FG005151 subjects
FG006147 subjects
FG007147 subjects
FG00851 subjects
FG00950 subjects
FG01050 subjects
FG01149 subjects
Safety Analysis Set
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. The Safety Set was used for analysis of safety except for the solicited adverse reactions (ARs). Participants were included in the vaccination group corresponding to the study injection they actually received.
FG00045 subjects
FG00145 subjects
FG00246 subjects
FG00344 subjects
FG00454 subjects
FG005150 subjects
FG006147 subjects
FG007147 subjects
FG00851 subjects
FG00950 subjects
FG01050 subjects
FG01149 subjects
Solicited Safety Set
Solicited Safety Set consisted of all participants in the Safety Set who contributed any solicited AR data. Participants were included in the vaccination group corresponding to the study injection they actually received.
FG00044 subjects
FG00145 subjects
FG00246 subjects
FG00344 subjects
FG00453 subjects
FG005149 subjects
FG006146 subjects
FG007145 subjects
FG00851 subjects
FG00950 subjects
FG01050 subjects
FG01149 subjects
Per-Protocol (PP) Set
PP Set consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response.
FG00041 subjects
FG00143 subjects
FG00244 subjects
FG00341 subjects
FG00452 subjects
FG005144 subjects
FG006138 subjects
FG007141 subjects
FG00848 subjects
FG00949 subjects
FG01047 subjects
FG01146 subjects
COMPLETED
Participants were considered to have completed the study if they completed the final visit on Day 181 (Month 6), 6 months after the investigational product administration on Day 1
FG00040 subjects
FG00139 subjects
FG00242 subjects
FG00338 subjects
FG00450 subjects
FG005135 subjects
FG006133 subjects
FG007139 subjects
FG00846 subjects
FG00947 subjects
FG01045 subjects
FG01141 subjects
NOT COMPLETED
FG0005 subjects
FG0016 subjects
FG0023 subjects
FG0037 subjects
FG0043 subjects
FG00518 subjects
FG00616 subjects
FG0079 subjects
FG0085 subjects
FG0093 subjects
FG0106 subjects
FG0119 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
Lost to Follow-up
FG0003 subjects
FG0014 subjects
FG0022 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0034 subjects
FG004
Safety Set: All randomly assigned participants who received the investigational product.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1/2: Placebo
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
BG001
Phase 1/2: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
BG002
Phase 1/2: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
BG003
Phase 1/2: mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
BG004
Phase 2 NH: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
BG005
Phase 2 NH: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
BG006
Phase 2 NH: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
BG007
Phase 2 NH: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
BG008
Phase 2 Extension: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1
BG009
Phase 2 Extension: mRNA-1010 6.25 ug
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
BG010
Phase 2 Extension: mRNA-1010 12.5 ug
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
BG011
Phase 2 Extension: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00045
BG00145
BG00246
BG00344
BG00454
BG005150
BG006147
BG007147
BG00851
BG00950
BG01050
BG01149
BG012878
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00052.0(18 to 90)
BG00148.2(18 to 74)
BG00252.2(19 to 83)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00023
BG00119
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG00112
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00038
BG00138
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Solicited Safety Set: Consisted of all participants in the Safety Set who contributed any solicited AR data. Dose groups for Phase 1/2, Phase 2 NH, and Phase 2 Extension by dose group and Afluria Quadrivalent 60 ug groups were combined for this assessment as pre-specified by the protocol. Combined data for >= 50 ug is also presented. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Count of Participants
Participants
7 days after vaccination
ID
Title
Description
OG000
Placebo
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
OG001
Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
OG002
mRNA-1010 6.25 ug
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
OG003
mRNA-1010 12.5 ug
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
OG004
mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
OG005
mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
OG006
mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
OG007
mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
OG008
mRNA-1010 >= 50 ug Overall
Units
Counts
Participants
OG00044
OG001104
OG00250
OG003
Title
Denominators
Categories
Grade 1
Title
Measurements
OG00012
OG00143
OG00222
OG003
Primary
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.
Safety Analysis Set: all randomly assigned participants who received the investigational product. Dose groups for Phase 1/2, Phase 2 NH, and Phase 2 Extension by dose group and Afluria Quadrivalent 60 ug groups were combined for this assessment as pre-specified by the protocol. Combined data for >= 50 ug is also presented. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Count of Participants
Participants
Up to 28 days after vaccination
ID
Title
Description
OG000
Placebo
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
OG001
Afluria Quadrivalent 60 ug
Primary
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.
Safety Analysis Set: all randomly assigned participants who received the investigational product. Dose groups for Phase 1/2, Phase 2 NH, and Phase 2 Extension by dose group and Afluria Quadrivalent 60 ug groups were combined for this assessment as pre-specified by the protocol. Combined data for >= 50 ug is also presented. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Count of Participants
Participants
Up to 6 months (end of study)
ID
Title
Description
OG000
Placebo
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
Primary
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.
Per-Protocol (PP) Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 29
ID
Title
Description
OG000
Phase 1/2: Placebo
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
OG001
Phase 1/2: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
OG002
Phase 1/2: mRNA-1010 100 ug
Primary
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.
PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 29
ID
Title
Description
OG000
Phase 2 NH: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
OG001
Phase 2 NH: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
OG002
Phase 2 NH: mRNA-1010 50 ug
Primary
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.
PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 29
ID
Title
Description
OG000
Phase 2 Extension: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
OG001
Phase 2 Extension: mRNA-1010 6.25 ug
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
OG002
Phase 2 Extension: mRNA-1010 12.5 ug
Primary
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 \
PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Number
95% Confidence Interval
percentage of participants
Day 29
ID
Title
Description
OG000
Phase 1/2: Placebo
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
OG001
Phase 1/2: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
OG002
Primary
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.
PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response.
Posted
Number
95% Confidence Interval
ratio
Day 1 (Baseline), Day 29
ID
Title
Description
OG000
Phase 1/2: Placebo
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
OG001
Phase 1/2: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
OG002
Phase 1/2: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
Primary
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 \
PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Number
95% Confidence Interval
percentage of participants
Day 29
ID
Title
Description
OG000
Phase 2 NH: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
OG001
Phase 2 NH: mRNA-1010 25 ug
Primary
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 \
PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Number
95% Confidence Interval
percentage of participants
Day 29
ID
Title
Description
OG000
Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
OG001
mRNA-1010 6.25 ug
Secondary
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.
PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 1 (Baseline), Day 8 and Day 181
ID
Title
Description
OG000
Phase 1/2: Placebo
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
OG001
Phase 1/2: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
OG002
Phase 1/2: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1
Secondary
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.
PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Number
95% Confidence Interval
ratio
Day 1 (Baseline), Day 8 and Day 181
ID
Title
Description
OG000
Phase 1/2: Placebo
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
OG001
Phase 1/2: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
OG002
Phase 1/2: mRNA-1010 100 ug
Secondary
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 \
PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 29
ID
Title
Description
OG000
Phase 2 NH: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
OG001
Phase 2 NH: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
Secondary
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.
PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Number
95% Confidence Interval
ratio
Day 29
ID
Title
Description
OG000
Phase 2 NH: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
OG001
Phase 2 NH: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
OG002
Phase 2 NH: mRNA-1010 50 ug
Secondary
Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29
PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Posted
Number
95% Confidence Interval
percentage of participants
Day 29
ID
Title
Description
OG000
Phase 2 NH: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
OG001
Phase 2 NH: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
OG002
Phase 2 NH: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
OG003
Phase 2 NH: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
Time Frame
Up to 6 months (Day 181, end of study)
Description
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received.
Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1/2: Placebo
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
1
45
2
45
26
45
EG001
Phase 1/2: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
0
45
0
45
39
45
EG002
Phase 1/2: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
0
46
0
46
44
46
EG003
Phase 1/2: mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
0
44
1
44
42
44
EG004
Phase 2 NH: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
0
54
1
54
37
54
EG005
Phase 2 NH: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
0
150
3
150
130
150
EG006
Phase 2 NH: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
0
147
5
147
133
147
EG007
Phase 2 NH: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
1
147
4
147
133
147
EG008
Phase 2 Extension: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
0
51
1
51
33
51
EG009
Phase 2 Extension: mRNA-1010 6.25 ug
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
1
50
2
50
45
50
EG010
Phase 2 Extension: mRNA-1010 12.5 ug
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
0
50
0
50
38
50
EG011
Phase 2 Extension: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
0
49
0
49
45
49
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected46 at risk
EG0030 affected44 at risk
EG0040 affected54 at risk
EG0050 affected150 at risk
EG0061 affected147 at risk
EG0070 affected147 at risk
EG0080 affected51 at risk
EG0090 affected50 at risk
EG0100 affected50 at risk
EG0110 affected49 at risk
Cystitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected46 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected46 at risk
EG003
Meningioma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected46 at risk
EG003
Renal cancer Stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)