Seasonal Influenza
Conditions
Keywords
Influenza vaccine, mRNA-1020, mRNA-1030, Moderna
Brief summary
The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1020, mRNA-1030, and mRNA-1010 vaccines against vaccine-matched influenza A and B strains.
Interventions
BIOLOGICALActive Comparator
Sterile liquid for injection
BIOLOGICALmRNA-1030
Sterile liquid for injection
BIOLOGICALmRNA-1020
Sterile liquid for injection
BIOLOGICALmRNA-1010
Sterile liquid for injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index of 18 kilograms (kg)/square meter (m\^2) to 35 kg/m\^2 (inclusive) at the Screening Visit. * 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 90 days following vaccine administration, and not currently breastfeeding.
Exclusion criteria
* Participant has had close contact to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening Visit. * Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1. * Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. * Participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 180 days prior to screening (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 or authorized vaccine, including COVID-19 vaccines, ≤28 days prior to the study injection (Day 1) or plans to receive a licensed or authorized vaccine within 28 days after the study injection. * Participant has received a Northern Hemisphere (NH) 2021-2022 seasonal influenza vaccine or any other influenza vaccine within 180 days prior to Day 1. * Participant tested positive for influenza by CDC-recommended testing methods within 180 days prior to Day 1. * Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study. Note: Other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Baseline (Day 1), Day 29 | ≥ z-fold rise from baseline at participant level is defined as a ≥ z x LLOQ for participants with baseline antibody level \< LLOQ, or a z-times or higher antibody level ratio in participants with baseline antibody level ≥ LLOQ. 95% CI was calculated using the Clopper-Pearson method. |
| Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | 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. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. |
| GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | 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. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. |
| Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Day 29 | Seroconversion at a participant level is defined as corresponding visit titer ≥ 4\*LLOQ (lower limit of quantification) if baseline is \< LLOQ or a 4-fold or greater rise if baseline is ≥ LLOQ in anti-HA antibodies. When LLOQ is 1:10, seroconversion is defined as a corresponding visit titer ≥ 1:40 if baseline is \< 1:10 or a 4-fold or greater rise if baseline is ≥ 1:10 in anti- HA antibodies measured by HAI assay. 95% CI was calculated using the Clopper-Pearson method. |
| Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 7 (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. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section and presented by each dose group separately. |
| Number of Participants With Unsolicited Adverse Events (AEs) | Up to Day 28 (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 dose group separately. |
| Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Day 1 through Day 181 | 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 dose group separately. |
| Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Day 29 | Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. |
| GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 29 | Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Days 8 and 181 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. |
| GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Days 8 and 181 | Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flublok Participants received Flublock by IM injection on Day 1. | 72 |
| mRNA-1010 Participants received mRNA-1010 by IM injection on Day 1. | 71 |
| mRNA-1030 Dose Level A Participants received mRNA-1030 Dose Level A by IM injection on Day 1. | 71 |
| mRNA-1020 Dose Level A Participants received mRNA-1020 Dose Level A by IM injection on Day 1. | 72 |
| mRNA-1030 Dose Level B Participants received mRNA-1030 Dose Level B by IM injection on Day 1. | 72 |
| mRNA-1020 Dose Level B Participants received mRNA-1020 Dose Level B by IM injection on Day 1. | 71 |
| mRNA-1030 Dose Level C Participants received mRNA-1030 Dose Level C by IM injection on Day 1. | 72 |
| mRNA-1020 Dose Level C Participants received mRNA-1020 Dose Level C by IM injection on Day 1. | 71 |
| Total | 572 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 6 | 0 | 1 | 6 | 3 | 3 | 2 | 1 |
| Overall Study | Other | 1 | 0 | 0 | 1 | 1 | 2 | 2 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 2 | 1 | 1 | 2 | 1 | 3 |
Baseline characteristics
| Characteristic | Flublok | mRNA-1010 | mRNA-1030 Dose Level A | mRNA-1020 Dose Level A | mRNA-1030 Dose Level B | mRNA-1020 Dose Level B | mRNA-1030 Dose Level C | mRNA-1020 Dose Level C | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 14.51 | 46.0 years STANDARD_DEVIATION 15.03 | 47.1 years STANDARD_DEVIATION 14.4 | 48.0 years STANDARD_DEVIATION 16.5 | 46.9 years STANDARD_DEVIATION 14.11 | 48.0 years STANDARD_DEVIATION 14.84 | 47.3 years STANDARD_DEVIATION 17.13 | 49.2 years STANDARD_DEVIATION 15.88 | 47.4 years STANDARD_DEVIATION 15.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 5 Participants | 6 Participants | 7 Participants | 6 Participants | 8 Participants | 4 Participants | 6 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 66 Participants | 65 Participants | 65 Participants | 65 Participants | 63 Participants | 67 Participants | 65 Participants | 519 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 3 Participants | 0 Participants | 4 Participants | 2 Participants | 4 Participants | 3 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 11 Participants | 15 Participants | 6 Participants | 13 Participants | 10 Participants | 7 Participants | 6 Participants | 74 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 60 Participants | 52 Participants | 51 Participants | 65 Participants | 54 Participants | 58 Participants | 61 Participants | 59 Participants | 460 Participants |
| Sex: Female, Male Female | 37 Participants | 33 Participants | 44 Participants | 42 Participants | 38 Participants | 41 Participants | 39 Participants | 40 Participants | 314 Participants |
| Sex: Female, Male Male | 35 Participants | 38 Participants | 27 Participants | 30 Participants | 34 Participants | 30 Participants | 33 Participants | 31 Participants | 258 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 72 | 0 / 71 | 0 / 71 | 0 / 72 | 0 / 72 | 0 / 71 | 0 / 72 | 0 / 71 |
| other Total, other adverse events | 58 / 71 | 67 / 71 | 62 / 71 | 66 / 71 | 63 / 72 | 62 / 67 | 70 / 72 | 69 / 70 |
| serious Total, serious adverse events | 2 / 71 | 1 / 71 | 1 / 71 | 1 / 71 | 1 / 72 | 0 / 67 | 2 / 72 | 4 / 70 |
Outcome results
Primary
Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay 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. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Time frame: Day 29
Population: PP Set consisted of all participants in the FAS who complied with injection schedule, complied with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, did not had influenza infection at baseline through Day 29, and had no major protocol deviations that impacted immune response. Number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those who were evaluable for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flublok | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 6.97 ratio |
| Flublok | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 9.93 ratio |
| Flublok | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 3.45 ratio |
| Flublok | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 3.75 ratio |
| mRNA-1010 | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 9.12 ratio |
| mRNA-1010 | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 2.48 ratio |
| mRNA-1010 | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 3.12 ratio |
| mRNA-1010 | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 7.73 ratio |
| mRNA-1030 Dose Level A | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 1.93 ratio |
| mRNA-1030 Dose Level A | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 2.83 ratio |
| mRNA-1030 Dose Level A | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 4.44 ratio |
| mRNA-1030 Dose Level A | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 5.29 ratio |
| mRNA-1020 Dose Level A | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 6.53 ratio |
| mRNA-1020 Dose Level A | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 8.56 ratio |
| mRNA-1020 Dose Level A | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 3.62 ratio |
| mRNA-1020 Dose Level A | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 2.37 ratio |
| mRNA-1030 Dose Level B | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 3.18 ratio |
| mRNA-1030 Dose Level B | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 6.83 ratio |
| mRNA-1030 Dose Level B | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 5.45 ratio |
| mRNA-1030 Dose Level B | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 2.40 ratio |
| mRNA-1020 Dose Level B | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 2.35 ratio |
| mRNA-1020 Dose Level B | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 8.39 ratio |
| mRNA-1020 Dose Level B | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 3.65 ratio |
| mRNA-1020 Dose Level B | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 7.68 ratio |
| mRNA-1030 Dose Level C | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 5.93 ratio |
| mRNA-1030 Dose Level C | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 2.50 ratio |
| mRNA-1030 Dose Level C | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 6.73 ratio |
| mRNA-1030 Dose Level C | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 2.98 ratio |
| mRNA-1020 Dose Level C | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 4.05 ratio |
| mRNA-1020 Dose Level C | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 6.79 ratio |
| mRNA-1020 Dose Level C | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 6.98 ratio |
| mRNA-1020 Dose Level C | Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 2.37 ratio |
Primary
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
Time frame: Day 29
Population: PP Set consisted of all participants in the FAS who complied with injection schedule, complied with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, did not had influenza infection at baseline through Day 29, and had no major protocol deviations that impacted immune response. Number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those who were evaluable for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flublok | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 724.69 titer |
| Flublok | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 354.11 titer |
| Flublok | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 151.68 titer |
| Flublok | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 277.06 titer |
| mRNA-1010 | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 245.01 titer |
| mRNA-1010 | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 316.36 titer |
| mRNA-1010 | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 498.43 titer |
| mRNA-1010 | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 88.57 titer |
| mRNA-1030 Dose Level A | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 328.44 titer |
| mRNA-1030 Dose Level A | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 191.74 titer |
| mRNA-1030 Dose Level A | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 239.78 titer |
| mRNA-1030 Dose Level A | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 86.86 titer |
| mRNA-1020 Dose Level A | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 472.81 titer |
| mRNA-1020 Dose Level A | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 263.95 titer |
| mRNA-1020 Dose Level A | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 86.88 titer |
| mRNA-1020 Dose Level A | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 249.81 titer |
| mRNA-1030 Dose Level B | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 237.78 titer |
| mRNA-1030 Dose Level B | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 105.92 titer |
| mRNA-1030 Dose Level B | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 211.86 titer |
| mRNA-1030 Dose Level B | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 387.92 titer |
| mRNA-1020 Dose Level B | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 246.78 titer |
| mRNA-1020 Dose Level B | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 82.86 titer |
| mRNA-1020 Dose Level B | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 255.44 titer |
| mRNA-1020 Dose Level B | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 378.34 titer |
| mRNA-1030 Dose Level C | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 255.31 titer |
| mRNA-1030 Dose Level C | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 431.61 titer |
| mRNA-1030 Dose Level C | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 91.71 titer |
| mRNA-1030 Dose Level C | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 283.59 titer |
| mRNA-1020 Dose Level C | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 300.62 titer |
| mRNA-1020 Dose Level C | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 75.56 titer |
| mRNA-1020 Dose Level C | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 243.62 titer |
| mRNA-1020 Dose Level C | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 527.55 titer |
Primary
GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI 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. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
Time frame: Day 29
Population: PP Set consisted of all participants in the FAS who complied with injection schedule, complied with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, did not had influenza infection at baseline through Day 29, and had no major protocol deviations that impacted immune response. Here, Number analyzed signifies those who were evaluable for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flublok | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 1.01 ratio |
| Flublok | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 0.94 ratio |
| Flublok | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 0.93 ratio |
| Flublok | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 1.00 ratio |
| mRNA-1010 | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 0.95 ratio |
| mRNA-1010 | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 1.07 ratio |
| mRNA-1010 | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 1.00 ratio |
| mRNA-1010 | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 0.99 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 1.42 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 4.21 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 3.18 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 3.57 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 2.18 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 4.61 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 5.78 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 6.76 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 4.54 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 4.31 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 3.65 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 1.82 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 7.74 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 6.80 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 6.29 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 2.35 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 4.87 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 1.75 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 4.30 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 4.47 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 8.01 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 6.49 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 8.36 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 2.38 ratio |
Primary
GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) 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.
Time frame: Day 29
Population: The Per Protocol (PP) Set consisted of all participants in the Full analysis set (FAS) who complied with injection schedule, complied with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, did not had influenza infection at baseline through Day 29, and had no major protocol deviations that impacted immune response. Here, Number analyzed signifies those who were evaluable for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flublok | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 103.61 titer |
| Flublok | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 20.49 titer |
| Flublok | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 69.93 titer |
| Flublok | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 183.03 titer |
| mRNA-1010 | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 78.26 titer |
| mRNA-1010 | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 97.52 titer |
| mRNA-1010 | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 21.09 titer |
| mRNA-1010 | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 215.34 titer |
| mRNA-1030 Dose Level A | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 69.21 titer |
| mRNA-1030 Dose Level A | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 837.52 titer |
| mRNA-1030 Dose Level A | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 163.35 titer |
| mRNA-1030 Dose Level A | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 268.39 titer |
| mRNA-1020 Dose Level A | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 1293.51 titer |
| mRNA-1020 Dose Level A | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 219.26 titer |
| mRNA-1020 Dose Level A | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 105.23 titer |
| mRNA-1020 Dose Level A | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 416.08 titer |
| mRNA-1030 Dose Level B | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 953.89 titer |
| mRNA-1030 Dose Level B | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 316.66 titer |
| mRNA-1030 Dose Level B | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 195.34 titer |
| mRNA-1030 Dose Level B | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 79.56 titer |
| mRNA-1020 Dose Level B | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 127.60 titer |
| mRNA-1020 Dose Level B | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 198.70 titer |
| mRNA-1020 Dose Level B | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 477.73 titer |
| mRNA-1020 Dose Level B | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 1441.95 titer |
| mRNA-1030 Dose Level C | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 170.25 titer |
| mRNA-1030 Dose Level C | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 998.57 titer |
| mRNA-1030 Dose Level C | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 92.57 titer |
| mRNA-1030 Dose Level C | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 316.71 titer |
| mRNA-1020 Dose Level C | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Yamagata Lineage | 1428.87 titer |
| mRNA-1020 Dose Level C | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 268.35 titer |
| mRNA-1020 Dose Level C | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 139.16 titer |
| mRNA-1020 Dose Level C | GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B/Victoria Lineage | 470.32 titer |
Primary
Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs)
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 dose group separately.
Time frame: Day 1 through Day 181
Population: The Safety Set consisted of all randomly assigned participants who received the investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flublok | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Medically-Attended AEs | 23 Participants |
| Flublok | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Adverse Event of Special Interest | 1 Participants |
| Flublok | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | AEs Leading to Withdrawal | 1 Participants |
| Flublok | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Serious Adverse Events | 2 Participants |
| mRNA-1010 | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Serious Adverse Events | 1 Participants |
| mRNA-1010 | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Adverse Event of Special Interest | 1 Participants |
| mRNA-1010 | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Medically-Attended AEs | 20 Participants |
| mRNA-1010 | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | AEs Leading to Withdrawal | 0 Participants |
| mRNA-1030 Dose Level A | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Medically-Attended AEs | 16 Participants |
| mRNA-1030 Dose Level A | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Serious Adverse Events | 1 Participants |
| mRNA-1030 Dose Level A | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Adverse Event of Special Interest | 1 Participants |
| mRNA-1030 Dose Level A | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | AEs Leading to Withdrawal | 0 Participants |
| mRNA-1020 Dose Level A | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Medically-Attended AEs | 24 Participants |
| mRNA-1020 Dose Level A | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Adverse Event of Special Interest | 1 Participants |
| mRNA-1020 Dose Level A | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | AEs Leading to Withdrawal | 0 Participants |
| mRNA-1020 Dose Level A | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Serious Adverse Events | 1 Participants |
| mRNA-1030 Dose Level B | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Serious Adverse Events | 1 Participants |
| mRNA-1030 Dose Level B | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | AEs Leading to Withdrawal | 0 Participants |
| mRNA-1030 Dose Level B | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Adverse Event of Special Interest | 1 Participants |
| mRNA-1030 Dose Level B | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Medically-Attended AEs | 18 Participants |
| mRNA-1020 Dose Level B | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Serious Adverse Events | 0 Participants |
| mRNA-1020 Dose Level B | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | AEs Leading to Withdrawal | 0 Participants |
| mRNA-1020 Dose Level B | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Adverse Event of Special Interest | 1 Participants |
| mRNA-1020 Dose Level B | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Medically-Attended AEs | 19 Participants |
| mRNA-1030 Dose Level C | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Serious Adverse Events | 2 Participants |
| mRNA-1030 Dose Level C | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Medically-Attended AEs | 17 Participants |
| mRNA-1030 Dose Level C | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | AEs Leading to Withdrawal | 0 Participants |
| mRNA-1030 Dose Level C | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Adverse Event of Special Interest | 0 Participants |
| mRNA-1020 Dose Level C | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Adverse Event of Special Interest | 0 Participants |
| mRNA-1020 Dose Level C | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | AEs Leading to Withdrawal | 0 Participants |
| mRNA-1020 Dose Level C | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Serious Adverse Events | 4 Participants |
| mRNA-1020 Dose Level C | Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) | Medically-Attended AEs | 23 Participants |
Primary
Number of Participants With Solicited Local and Systemic Adverse Reactions (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. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section and presented by each dose group separately.
Time frame: Up to Day 7 (7 days after vaccination)
Population: The Solicited Safety Set consisted of all participants in the Safety Set who contributed any solicited AR data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flublok | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Local ARs | 37 Participants |
| Flublok | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Systemic ARs | 32 Participants |
| mRNA-1010 | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Local ARs | 63 Participants |
| mRNA-1010 | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Systemic ARs | 61 Participants |
| mRNA-1030 Dose Level A | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Local ARs | 59 Participants |
| mRNA-1030 Dose Level A | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Systemic ARs | 44 Participants |
| mRNA-1020 Dose Level A | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Local ARs | 60 Participants |
| mRNA-1020 Dose Level A | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Systemic ARs | 57 Participants |
| mRNA-1030 Dose Level B | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Local ARs | 57 Participants |
| mRNA-1030 Dose Level B | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Systemic ARs | 55 Participants |
| mRNA-1020 Dose Level B | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Local ARs | 58 Participants |
| mRNA-1020 Dose Level B | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Systemic ARs | 58 Participants |
| mRNA-1030 Dose Level C | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Systemic ARs | 64 Participants |
| mRNA-1030 Dose Level C | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Local ARs | 67 Participants |
| mRNA-1020 Dose Level C | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Local ARs | 67 Participants |
| mRNA-1020 Dose Level C | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited Systemic ARs | 64 Participants |
Primary
Number of Participants With Unsolicited Adverse Events (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 dose group separately.
Time frame: Up to Day 28 (28 days after vaccination)
Population: The Safety Set consisted of all randomly assigned participants who received the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flublok | Number of Participants With Unsolicited Adverse Events (AEs) | 10 Participants |
| mRNA-1010 | Number of Participants With Unsolicited Adverse Events (AEs) | 17 Participants |
| mRNA-1030 Dose Level A | Number of Participants With Unsolicited Adverse Events (AEs) | 6 Participants |
| mRNA-1020 Dose Level A | Number of Participants With Unsolicited Adverse Events (AEs) | 15 Participants |
| mRNA-1030 Dose Level B | Number of Participants With Unsolicited Adverse Events (AEs) | 11 Participants |
| mRNA-1020 Dose Level B | Number of Participants With Unsolicited Adverse Events (AEs) | 15 Participants |
| mRNA-1030 Dose Level C | Number of Participants With Unsolicited Adverse Events (AEs) | 12 Participants |
| mRNA-1020 Dose Level C | Number of Participants With Unsolicited Adverse Events (AEs) | 21 Participants |
Primary
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
≥ z-fold rise from baseline at participant level is defined as a ≥ z x LLOQ for participants with baseline antibody level \< LLOQ, or a z-times or higher antibody level ratio in participants with baseline antibody level ≥ LLOQ. 95% CI was calculated using the Clopper-Pearson method.
Time frame: Baseline (Day 1), Day 29
Population: PP Set consisted of all participants in the FAS who complied with injection schedule, complied with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, did not had influenza infection at baseline through Day 29, and had no major protocol deviations that impacted immune response.Number of participants analyzed signifies those who were evaluable for this outcome measure. Number analyzed signifies those who were evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flublok | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 2-fold Rise from Baseline | 87.7 Percentage of Participants |
| Flublok | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 4-fold Rise from Baseline | 47.7 Percentage of Participants |
| Flublok | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 3-fold Rise from Baseline | 47.7 Percentage of Participants |
| Flublok | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 4-fold Rise from Baseline | 66.2 Percentage of Participants |
| Flublok | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 2-fold Rise from Baseline | 84.6 Percentage of Participants |
| Flublok | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 4-fold Rise from Baseline | 69.2 Percentage of Participants |
| Flublok | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 2-fold Rise from Baseline | 78.5 Percentage of Participants |
| Flublok | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 3-fold Rise from Baseline | 47.7 Percentage of Participants |
| Flublok | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 3-fold Rise from Baseline | 67.7 Percentage of Participants |
| Flublok | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 4-fold Rise from Baseline | 46.2 Percentage of Participants |
| Flublok | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 3-fold Rise from Baseline | 69.2 Percentage of Participants |
| Flublok | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 2-fold Rise from Baseline | 75.4 Percentage of Participants |
| mRNA-1010 | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 3-fold Rise from Baseline | 19.7 Percentage of Participants |
| mRNA-1010 | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 2-fold Rise from Baseline | 65.6 Percentage of Participants |
| mRNA-1010 | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 4-fold Rise from Baseline | 36.1 Percentage of Participants |
| mRNA-1010 | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 3-fold Rise from Baseline | 77.0 Percentage of Participants |
| mRNA-1010 | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 4-fold Rise from Baseline | 75.4 Percentage of Participants |
| mRNA-1010 | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 3-fold Rise from Baseline | 36.1 Percentage of Participants |
| mRNA-1010 | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 2-fold Rise from Baseline | 96.7 Percentage of Participants |
| mRNA-1010 | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 2-fold Rise from Baseline | 93.4 Percentage of Participants |
| mRNA-1010 | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 2-fold Rise from Baseline | 85.2 Percentage of Participants |
| mRNA-1010 | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 3-fold Rise from Baseline | 75.4 Percentage of Participants |
| mRNA-1010 | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 4-fold Rise from Baseline | 19.7 Percentage of Participants |
| mRNA-1010 | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 4-fold Rise from Baseline | 73.8 Percentage of Participants |
| mRNA-1030 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 4-fold Rise from Baseline | 37.3 Percentage of Participants |
| mRNA-1030 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 4-fold Rise from Baseline | 50.0 Percentage of Participants |
| mRNA-1030 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 4-fold Rise from Baseline | 14.9 Percentage of Participants |
| mRNA-1030 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 2-fold Rise from Baseline | 46.3 Percentage of Participants |
| mRNA-1030 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 3-fold Rise from Baseline | 37.3 Percentage of Participants |
| mRNA-1030 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 3-fold Rise from Baseline | 14.9 Percentage of Participants |
| mRNA-1030 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 4-fold Rise from Baseline | 56.7 Percentage of Participants |
| mRNA-1030 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 3-fold Rise from Baseline | 56.7 Percentage of Participants |
| mRNA-1030 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 2-fold Rise from Baseline | 80.3 Percentage of Participants |
| mRNA-1030 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 3-fold Rise from Baseline | 51.5 Percentage of Participants |
| mRNA-1030 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 2-fold Rise from Baseline | 77.6 Percentage of Participants |
| mRNA-1030 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 2-fold Rise from Baseline | 80.6 Percentage of Participants |
| mRNA-1020 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 2-fold Rise from Baseline | 84.1 Percentage of Participants |
| mRNA-1020 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 2-fold Rise from Baseline | 90.5 Percentage of Participants |
| mRNA-1020 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 4-fold Rise from Baseline | 65.1 Percentage of Participants |
| mRNA-1020 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 3-fold Rise from Baseline | 74.6 Percentage of Participants |
| mRNA-1020 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 2-fold Rise from Baseline | 68.3 Percentage of Participants |
| mRNA-1020 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 3-fold Rise from Baseline | 65.1 Percentage of Participants |
| mRNA-1020 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 4-fold Rise from Baseline | 52.4 Percentage of Participants |
| mRNA-1020 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 4-fold Rise from Baseline | 28.6 Percentage of Participants |
| mRNA-1020 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 4-fold Rise from Baseline | 74.6 Percentage of Participants |
| mRNA-1020 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 2-fold Rise from Baseline | 84.1 Percentage of Participants |
| mRNA-1020 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 3-fold Rise from Baseline | 28.6 Percentage of Participants |
| mRNA-1020 Dose Level A | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 3-fold Rise from Baseline | 52.4 Percentage of Participants |
| mRNA-1030 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 3-fold Rise from Baseline | 30.2 Percentage of Participants |
| mRNA-1030 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 2-fold Rise from Baseline | 92.1 Percentage of Participants |
| mRNA-1030 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 3-fold Rise from Baseline | 71.4 Percentage of Participants |
| mRNA-1030 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 4-fold Rise from Baseline | 71.4 Percentage of Participants |
| mRNA-1030 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 2-fold Rise from Baseline | 88.9 Percentage of Participants |
| mRNA-1030 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 3-fold Rise from Baseline | 60.3 Percentage of Participants |
| mRNA-1030 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 4-fold Rise from Baseline | 60.3 Percentage of Participants |
| mRNA-1030 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 2-fold Rise from Baseline | 66.7 Percentage of Participants |
| mRNA-1030 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 4-fold Rise from Baseline | 30.2 Percentage of Participants |
| mRNA-1030 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 2-fold Rise from Baseline | 87.3 Percentage of Participants |
| mRNA-1030 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 3-fold Rise from Baseline | 41.3 Percentage of Participants |
| mRNA-1030 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 4-fold Rise from Baseline | 41.3 Percentage of Participants |
| mRNA-1020 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 4-fold Rise from Baseline | 71.7 Percentage of Participants |
| mRNA-1020 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 4-fold Rise from Baseline | 76.7 Percentage of Participants |
| mRNA-1020 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 2-fold Rise from Baseline | 91.7 Percentage of Participants |
| mRNA-1020 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 2-fold Rise from Baseline | 93.3 Percentage of Participants |
| mRNA-1020 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 4-fold Rise from Baseline | 45.0 Percentage of Participants |
| mRNA-1020 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 2-fold Rise from Baseline | 93.3 Percentage of Participants |
| mRNA-1020 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 3-fold Rise from Baseline | 25.0 Percentage of Participants |
| mRNA-1020 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 3-fold Rise from Baseline | 76.7 Percentage of Participants |
| mRNA-1020 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 3-fold Rise from Baseline | 71.7 Percentage of Participants |
| mRNA-1020 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 4-fold Rise from Baseline | 25.0 Percentage of Participants |
| mRNA-1020 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 2-fold Rise from Baseline | 71.7 Percentage of Participants |
| mRNA-1020 Dose Level B | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 3-fold Rise from Baseline | 45.0 Percentage of Participants |
| mRNA-1030 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 4-fold Rise from Baseline | 65.2 Percentage of Participants |
| mRNA-1030 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 3-fold Rise from Baseline | 25.8 Percentage of Participants |
| mRNA-1030 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 3-fold Rise from Baseline | 65.2 Percentage of Participants |
| mRNA-1030 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 4-fold Rise from Baseline | 25.8 Percentage of Participants |
| mRNA-1030 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 2-fold Rise from Baseline | 92.4 Percentage of Participants |
| mRNA-1030 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 2-fold Rise from Baseline | 87.9 Percentage of Participants |
| mRNA-1030 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 4-fold Rise from Baseline | 69.7 Percentage of Participants |
| mRNA-1030 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 3-fold Rise from Baseline | 69.7 Percentage of Participants |
| mRNA-1030 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 4-fold Rise from Baseline | 40.9 Percentage of Participants |
| mRNA-1030 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 3-fold Rise from Baseline | 40.9 Percentage of Participants |
| mRNA-1030 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 2-fold Rise from Baseline | 92.4 Percentage of Participants |
| mRNA-1030 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 2-fold Rise from Baseline | 71.2 Percentage of Participants |
| mRNA-1020 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 2-fold Rise from Baseline | 68.9 Percentage of Participants |
| mRNA-1020 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 4-fold Rise from Baseline | 23.0 Percentage of Participants |
| mRNA-1020 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 4-fold Rise from Baseline | 82.0 Percentage of Participants |
| mRNA-1020 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 3-fold Rise from Baseline | 54.1 Percentage of Participants |
| mRNA-1020 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 4-fold Rise from Baseline | 54.1 Percentage of Participants |
| mRNA-1020 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 4-fold Rise from Baseline | 67.2 Percentage of Participants |
| mRNA-1020 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 2-fold Rise from Baseline | 95.1 Percentage of Participants |
| mRNA-1020 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Yamagata Lineage: ≥ 2-fold Rise from Baseline | 93.4 Percentage of Participants |
| mRNA-1020 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza B/Victoria Lineage: ≥ 3-fold Rise from Baseline | 23.0 Percentage of Participants |
| mRNA-1020 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 2-fold Rise from Baseline | 98.4 Percentage of Participants |
| mRNA-1020 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H1N1 Antibody: ≥ 3-fold Rise from Baseline | 68.9 Percentage of Participants |
| mRNA-1020 Dose Level C | Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay | Influenza A H3N2 Antibody: ≥ 3-fold Rise from Baseline | 82.0 Percentage of Participants |
Primary
Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Seroconversion at a participant level is defined as corresponding visit titer ≥ 4\*LLOQ (lower limit of quantification) if baseline is \< LLOQ or a 4-fold or greater rise if baseline is ≥ LLOQ in anti-HA antibodies. When LLOQ is 1:10, seroconversion is defined as a corresponding visit titer ≥ 1:40 if baseline is \< 1:10 or a 4-fold or greater rise if baseline is ≥ 1:10 in anti- HA antibodies measured by HAI assay. 95% CI was calculated using the Clopper-Pearson method.
Time frame: Day 29
Population: PP Set consisted of all participants in the FAS who complied with injection schedule, complied with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, did not had influenza infection at baseline through Day 29, and had no major protocol deviations that impacted immune response. Number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those who were evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flublok | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H1N1 Antibody | 66.2 percentage of participants |
| Flublok | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H3N2 Antibody | 69.2 percentage of participants |
| Flublok | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Victoria Lineage | 46.2 percentage of participants |
| Flublok | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Yamagata Lineage | 47.7 percentage of participants |
| mRNA-1010 | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Yamagata Lineage | 36.1 percentage of participants |
| mRNA-1010 | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H3N2 Antibody | 73.8 percentage of participants |
| mRNA-1010 | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H1N1 Antibody | 75.4 percentage of participants |
| mRNA-1010 | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Victoria Lineage | 19.7 percentage of participants |
| mRNA-1030 Dose Level A | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H1N1 Antibody | 56.7 percentage of participants |
| mRNA-1030 Dose Level A | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Yamagata Lineage | 37.3 percentage of participants |
| mRNA-1030 Dose Level A | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H3N2 Antibody | 50.0 percentage of participants |
| mRNA-1030 Dose Level A | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Victoria Lineage | 14.9 percentage of participants |
| mRNA-1020 Dose Level A | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H1N1 Antibody | 74.6 percentage of participants |
| mRNA-1020 Dose Level A | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H3N2 Antibody | 65.1 percentage of participants |
| mRNA-1020 Dose Level A | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Victoria Lineage | 28.6 percentage of participants |
| mRNA-1020 Dose Level A | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Yamagata Lineage | 52.4 percentage of participants |
| mRNA-1030 Dose Level B | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Yamagata Lineage | 41.3 percentage of participants |
| mRNA-1030 Dose Level B | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Victoria Lineage | 30.2 percentage of participants |
| mRNA-1030 Dose Level B | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H3N2 Antibody | 60.3 percentage of participants |
| mRNA-1030 Dose Level B | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H1N1 Antibody | 71.4 percentage of participants |
| mRNA-1020 Dose Level B | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Yamagata Lineage | 45.0 percentage of participants |
| mRNA-1020 Dose Level B | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Victoria Lineage | 25.0 percentage of participants |
| mRNA-1020 Dose Level B | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H3N2 Antibody | 76.7 percentage of participants |
| mRNA-1020 Dose Level B | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H1N1 Antibody | 71.7 percentage of participants |
| mRNA-1030 Dose Level C | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Yamagata Lineage | 40.9 percentage of participants |
| mRNA-1030 Dose Level C | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H1N1 Antibody | 69.7 percentage of participants |
| mRNA-1030 Dose Level C | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Victoria Lineage | 25.8 percentage of participants |
| mRNA-1030 Dose Level C | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H3N2 Antibody | 65.2 percentage of participants |
| mRNA-1020 Dose Level C | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H3N2 Antibody | 82.0 percentage of participants |
| mRNA-1020 Dose Level C | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Victoria Lineage | 23.0 percentage of participants |
| mRNA-1020 Dose Level C | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza B/Yamagata Lineage | 54.1 percentage of participants |
| mRNA-1020 Dose Level C | Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Influenza A H1N1 Antibody | 67.2 percentage of participants |
Secondary
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays 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. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
Time frame: Days 8 and 181
Population: PP Set consisted of all participants in the FAS who comply with injection schedule, comply with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, do not have influenza infection at baseline through Day 29, and have no major protocol deviations that impact immune response. Number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those who were evaluable for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 2.71 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.07 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 1.62 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 3.37 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 4.37 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 1.02 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 1.12 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 2.92 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 3.25 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 1.06 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 0.97 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 2.13 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 1.03 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 1.21 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.00 ratio |
| Flublok | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 3.03 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 3.07 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 0.99 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 1.00 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 1.36 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 0.97 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 4.32 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 1.01 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 3.29 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 3.84 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 0.99 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 0.96 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 0.98 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 0.97 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 2.31 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 1.88 ratio |
| mRNA-1010 | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 2.25 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 2.78 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 2.69 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 2.28 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 1.83 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 2.17 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 1.36 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.04 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.20 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 2.54 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 2.28 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 2.78 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 2.16 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 3.22 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 2.11 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 2.78 ratio |
| mRNA-1030 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 2.24 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 1.67 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 3.96 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 4.78 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 2.31 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.52 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 3.36 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.44 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 3.97 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 2.73 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 3.22 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 2.81 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 3.01 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 2.05 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 3.34 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 2.33 ratio |
| mRNA-1020 Dose Level A | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 3.44 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 3.92 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 2.27 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 3.24 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.16 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 2.89 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 2.69 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 2.55 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 2.52 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 3.58 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 1.45 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.39 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 2.64 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 3.18 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 2.63 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 3.65 ratio |
| mRNA-1030 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 2.14 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 3.65 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.61 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 3.75 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.50 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 2.03 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 3.67 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 3.20 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 2.69 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 4.71 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 2.63 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 3.52 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 5.72 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 3.46 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 4.16 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 3.12 ratio |
| mRNA-1020 Dose Level B | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 1.57 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 2.80 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 3.84 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 2.83 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.18 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 4.04 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 1.26 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 3.43 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 4.02 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 2.53 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 3.57 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.43 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 4.65 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 2.68 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 1.78 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 2.45 ratio |
| mRNA-1030 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 2.36 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 3.01 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.47 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 5.04 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 1.53 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 1.79 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 6.35 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 3.41 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 3.65 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 2.08 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 3.12 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 2.73 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 1.64 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 4.32 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 3.61 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 4.57 ratio |
| mRNA-1020 Dose Level C | GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 4.07 ratio |
Secondary
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays 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.
Time frame: Days 8 and 181
Population: PP Set consisted of all participants in the FAS who comply with injection schedule, comply with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, do not have influenza infection at baseline through Day 29, and have no major protocol deviations that impact immune response. Number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those who were evaluable for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 140.58 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 203.10 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 193.05 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 178.85 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 348.67 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 98.26 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 250.04 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 134.94 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 109.63 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 104.82 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 26.70 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 21.34 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 73.55 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 82.87 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 208.04 titer |
| Flublok | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 193.09 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 96.45 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 80.91 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 131.90 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 188.07 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 80.00 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 164.69 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 19.13 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 242.49 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 19.59 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 64.82 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 104.47 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 170.30 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 79.11 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 220.14 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 93.55 titer |
| mRNA-1010 | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 212.57 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 209.38 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 138.81 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 90.12 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 167.43 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 151.14 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 149.90 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 161.64 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 640.00 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 119.76 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 93.28 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 138.97 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 50.91 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 55.15 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 83.56 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 414.99 titer |
| mRNA-1030 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 136.01 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 281.56 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 121.39 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 914.65 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 116.43 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 83.35 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 80.49 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 171.63 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 113.17 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 145.36 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 149.29 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 64.20 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 625.38 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 50.43 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 236.98 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 207.90 titer |
| mRNA-1020 Dose Level A | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 171.47 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 195.70 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 114.40 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 823.47 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 195.65 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 238.47 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 105.33 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 195.04 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 91.80 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 124.35 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 139.91 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 62.87 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 151.44 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 134.16 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 141.74 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 50.86 titer |
| mRNA-1030 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 536.70 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 136.01 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 1064.75 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 126.99 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 227.71 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 101.00 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 330.57 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 74.58 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 113.74 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 693.91 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 186.93 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 111.81 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 120.48 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 64.15 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 251.07 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 138.63 titer |
| mRNA-1020 Dose Level B | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 74.64 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 146.30 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 149.60 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 281.89 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 216.55 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 135.30 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 106.39 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 190.79 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 73.44 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 114.91 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 100.25 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 69.34 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 828.90 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 282.64 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 63.97 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 529.22 titer |
| mRNA-1030 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 182.97 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay | 93.22 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay | 184.60 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay | 55.26 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay | 161.83 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay | 91.30 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay | 79.31 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay | 164.66 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay | 64.08 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay | 131.15 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay | 365.16 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay | 214.99 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay | 181.63 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay | 209.90 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay | 1085.27 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay | 344.86 titer |
| mRNA-1020 Dose Level C | GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay | 604.65 titer |