Influenza, SARS-CoV-2
Conditions
Keywords
mRNA-1083, mRNA-1083 Vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, Influenza Vaccine, Moderna, Influenza
Brief summary
The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults. The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and \<50 years of age.
Detailed description
Part 1: Participants will be enrolled into 1 of 2 age cohorts: Cohort A for adults ≥65 to \<80 years of age or Cohort B for adults ≥18 to \<65 year of age. In Cohort A, approximately 600 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since September 2022). In Cohort B, approximately 624 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by 2 age groups: ≥18 to \<50 years and ≥50 to \<65 years of age and by influenza vaccine status in the most recent influenza season (received or not received since September 2022). Part 2: Approximately, 520 participants between ≥18 to \<50 years of age will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since Sept 2023).
Interventions
BIOLOGICALInfluenza Vaccine 1
quadrivalent seasonal influenza vaccine
BIOLOGICALmRNA-1083.1
Sterile liquid for injection
BIOLOGICALmRNA-1083.2
Sterile liquid for injection
BIOLOGICALmRNA-1083.3
Sterile liquid for injection
BIOLOGICALInvestigational Influenza Vaccine 1
Sterile liquid for injection
BIOLOGICALInvestigational COVID-19 Vaccine 1
Sterile liquid for injection
BIOLOGICALCOVID-19 Vaccine 1
Sterile liquid for injection
BIOLOGICALInvestigational Influenza Vaccine 2
Sterile liquid for injection
BIOLOGICALInfluenza Vaccine 2
quadrivalent seasonal influenza vaccine
BIOLOGICALmRNA-1083
Sterile liquid for injection
BIOLOGICALInvestigational COVID-19 Vaccine 2
Sterile liquid for injection
BIOLOGICALCOVID-19 Vaccine 2
Sterile liquid for injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: Part 1 (Phase 1/2) * Adults ≥18 to \<80 years of age at the time of consent. * Body mass index (BMI) of 18 kilograms (kg)/square meter (m\^2) to 35 kg/m\^2 (inclusive) at the Screening Visit. * Healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests. * 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. * Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥120 days prior to Day 1. Part 2 (Phase 2 Extension) * Adults ≥18 to \<50 years of age at the time of consent. * BMI of 18 kg/m\^2 to 35 kg/m\^2 (inclusive) at the Screening Visit. * Healthy as determined by medical evaluation, including medical history, and physical examination. * 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. * Have received at least 2 doses of locally authorized or approved COVID-19 vaccines and last dose was ≥90 days prior to Day 1. Key
Exclusion criteria
Part 1 (Phase 1/2) and Part 2 (Phase 2 Extension) * 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 drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results. * Participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed. * Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration. * Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1. * Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1. * Participant has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 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 clinical trial. * Working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel, or resides in a nursing home. Part 2 (Phase 2 Extension) Only * Participants who enrolled in Part 1 of the mRNA-1083-P101 (Phase 1/2) study. Note: Other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Up to 7 days after study injection | Solicited ARs (local and systemic) were reported by participants an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. |
| Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Up to 28 days after study injection | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Severity for all unsolicited AEs was determined by the Investigator based upon medical judgment and graded as Mild, Moderate or Severe. Number of participants with unsolicited AEs (SAEs and non-serious AEs) and severe AEs up to 28 days post-vaccination are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section. |
| Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | Day 1 through Day 181 | An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs were protocol-defined medical concepts. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site. Number of participants with SAEs, AESIs, MAAEs, and AEs leading to study discontinuation up to Day 181 are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section. |
| Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Day 29 | Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 \* LLOQ. Values greater than the upper limit of quantification (ULOQ) were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values for geometric mean (GM) titer, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure. |
| Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) | Day 29 | SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 arbitrary units (AU)/milliliter (mL) for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM concentration, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure. |
| Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Day 29 | Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure. |
| Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA | Day 29 | SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure. |
| Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Baseline to Day 29 | Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer. Arms based on the applicable vaccine for this Outcome Measure. |
| Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | Baseline to Day 29 | SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 \* LLOQ if Baseline neutralizing antibody (nAb) level was \< LLOQ, or ≥4-fold rise if Baseline nAb level was ≥ LLOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. Arms based on the applicable vaccine for this Outcome Measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | Day 181 | SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. |
| Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Baseline (Day 1), Day 29, and Day 181 | Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ were replaced by 0.5 \* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 10 and ULOQ = 640 for Influenza A H1N1 and Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 320 for Influenza B/ Victoria, and LLOQ = 10 and ULOQ = 640 for Influenza B/Yamagata antibody. 95% CI was calculated based on t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. |
| Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | Baseline (Day 1) to Day 181 | SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 \* LLOQ if Baseline nAb level was \< LLOQ, or ≥4-fold rise if Baseline nAb level was ≥ LLOQ. PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response. |
| Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Baseline (Day 1) to Day 181 | Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer. PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response. |
| Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | Baseline (Day 1), Day 29, and Day 181 | SARS-CoV-2 strain included BA.4/5 and D614G antibody. Antibody values reported as below LLOQ were replaced by 0.5 \* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 53 and ULOQ = 71376 for SARS-CoV-2 BA.4/5 antibody and LLOQ = 74.1 and ULOQ = 184317 for SARS-CoV-2 D614G antibody. 95% CI was calculated based on t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. |
| Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Day 29 and Day 181 | Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ were replaced by 0.5 \* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 10 and ULOQ = 640 for Influenza A H1N1 and Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 320 for Influenza B/Victoria, and LLOQ = 10 and ULOQ = 640 for Influenza B/Yamagata antibody. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. |
| Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | Day 29 and Day 181 | SARS-CoV-2 strain included BA.4/5 and D614G antibody. Antibody values reported as below LLOQ were replaced by 0.5 \* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 53 and ULOQ = 71376 for SARS-CoV-2 BA.4/5 antibody and LLOQ = 74.1 and ULOQ = 184317 for SARS-CoV-2 D614G antibody. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. |
| Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Baseline (Day 1) to Day 29, and Day 181 | Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer \< 1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post vaccination HAI antibody titer. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. |
| Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | Baseline (Day 1) to Day 29, and Day 181 | SARS-CoV-2 strain included BA.4/5 and D614G antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 x LLOQ if baseline nAb level was \<LLOQ, or ≥4 fold rise if baseline nAb level was ≥LLOQ. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. |
| Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Baseline (Day 1), Day 181 | Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure. |
| Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | Baseline (Day 1), Day 181 | SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 arbitrary units (AU)/milliliter (mL) for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM concentration, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure. |
| Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Day 181 | Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ replaced by 0.5 \* LLOQ. Values greater than ULOQ converted to ULOQ. LLOQ= 10, ULOQ= 3620 for Influenza A H1N1, LLOQ= 10, ULOQ= 5120 for Influenza A H3N2, LLOQ= 10, ULOQ= 1356 for Influenza B/Victoria-lineage, and LLOQ= 10, ULOQ= 1280 for Influenza B/Yamagata-lineage. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 Participants received a single IM injection of Influenza Vaccine 1 on Day 1. | 54 |
| Part 1 Cohort A13: Influenza Vaccine 2 Participants received a single IM injection of Influenza Vaccine 2 on Day 1. | 53 |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1. | 54 |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1. | 51 |
| Part 1 Cohort A10: COVID-19 Vaccine 1 Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1. | 54 |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1. | 52 |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1. | 51 |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1. | 33 |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1. | 54 |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1. | 54 |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1. | 33 |
| Part 1 Cohort A7: mRNA-1083.3 Participants received a single IM injection of mRNA-1083.3 on Day 1. | 53 |
| Part 1 Cohort B12: Influenza Vaccine 1 Participants received a single IM injection of Influenza Vaccine 1 on Day 1. | 52 |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1. | 55 |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1. | 55 |
| Part 1 Cohort B10: COVID-19 Vaccine 1 Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1. | 53 |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1. | 55 |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1. | 55 |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1. | 56 |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1. | 37 |
| Part 1 Cohort B4: mRNA-1083.2 Dose Level 1 Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1. | 55 |
| Part 1 Cohort B5: mRNA-1083.2 Dose Level 2 Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1. | 55 |
| Part 1 Cohort B6: mRNA-1083.2 Dose Level 3 Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1. | 38 |
| Part 1 Cohort B7: mRNA-1083.3 Participants received a single IM injection of mRNA-1083.3 on Day 1. | 54 |
| Part 2: Influenza Vaccine 1 Participants received a single IM injection of Influenza Vaccine 1 on Day 1. | 40 |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 1 Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1. | 39 |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 2 Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1. | 40 |
| Part 2: COVID-19 Vaccine 2 Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1. | 42 |
| Part 2: Investigational COVID-19 Vaccine 2 Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1. | 40 |
| Part 2: mRNA-1083 Composition 1 Dose Level 1 Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1. | 40 |
| Part 2: mRNA-1083 Composition 1 Dose Level 2 Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1. | 42 |
| Part 2: mRNA-1083 Composition 1 Dose Level 3 Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1. | 41 |
| Part 2: mRNA-1083 Composition 1 Dose Level 4 Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1. | 41 |
| Part 2: mRNA-1083 Composition 2 Dose Level 1 Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1. | 40 |
| Part 2: mRNA-1083 Composition 2 Dose Level 2 Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1. | 40 |
| Part 2: mRNA-1083 Composition 2 Dose Level 3 Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1. | 40 |
| Part 2: mRNA-1083 Composition 2 Dose Level 4 Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1. | 42 |
| Total | 1,743 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 | FG027 | FG028 | FG029 | FG030 | FG031 | FG032 | FG033 | FG034 | FG035 | FG036 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 1 | 2 | 1 | 1 | 2 | 1 | 4 | 1 | 2 | 1 | 5 | 0 | 3 | 2 | 1 | 3 | 4 |
| Overall Study | Other Than Specified | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Part 1 Cohort A12: Influenza Vaccine 1 | Part 1 Cohort A13: Influenza Vaccine 2 | Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1 Cohort A7: mRNA-1083.3 | Part 1 Cohort B12: Influenza Vaccine 1 | Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1 Cohort B4: mRNA-1083.2 Dose Level 1 | Part 1 Cohort B5: mRNA-1083.2 Dose Level 2 | Part 1 Cohort B6: mRNA-1083.2 Dose Level 3 | Part 1 Cohort B7: mRNA-1083.3 | Part 2: Influenza Vaccine 1 | Part 2: Investigational Influenza Vaccine 1 Dose Level 1 | Part 2: Investigational Influenza Vaccine 1 Dose Level 2 | Part 2: COVID-19 Vaccine 2 | Part 2: Investigational COVID-19 Vaccine 2 | Part 2: mRNA-1083 Composition 1 Dose Level 1 | Part 2: mRNA-1083 Composition 1 Dose Level 2 | Part 2: mRNA-1083 Composition 1 Dose Level 3 | Part 2: mRNA-1083 Composition 1 Dose Level 4 | Part 2: mRNA-1083 Composition 2 Dose Level 1 | Part 2: mRNA-1083 Composition 2 Dose Level 2 | Part 2: mRNA-1083 Composition 2 Dose Level 3 | Part 2: mRNA-1083 Composition 2 Dose Level 4 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 54 Participants | 53 Participants | 54 Participants | 51 Participants | 54 Participants | 52 Participants | 51 Participants | 33 Participants | 54 Participants | 54 Participants | 33 Participants | 53 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 596 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 52 Participants | 55 Participants | 55 Participants | 53 Participants | 55 Participants | 55 Participants | 56 Participants | 37 Participants | 55 Participants | 55 Participants | 38 Participants | 54 Participants | 40 Participants | 39 Participants | 40 Participants | 42 Participants | 40 Participants | 40 Participants | 42 Participants | 41 Participants | 41 Participants | 40 Participants | 40 Participants | 40 Participants | 42 Participants | 1147 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 6 Participants | 3 Participants | 4 Participants | 6 Participants | 8 Participants | 4 Participants | 5 Participants | 4 Participants | 3 Participants | 8 Participants | 8 Participants | 2 Participants | 8 Participants | 7 Participants | 4 Participants | 7 Participants | 5 Participants | 5 Participants | 9 Participants | 7 Participants | 5 Participants | 5 Participants | 7 Participants | 3 Participants | 4 Participants | 2 Participants | 8 Participants | 4 Participants | 10 Participants | 11 Participants | 2 Participants | 5 Participants | 10 Participants | 6 Participants | 6 Participants | 209 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 49 Participants | 47 Participants | 47 Participants | 50 Participants | 44 Participants | 43 Participants | 28 Participants | 49 Participants | 49 Participants | 30 Participants | 45 Participants | 44 Participants | 51 Participants | 47 Participants | 46 Participants | 51 Participants | 47 Participants | 50 Participants | 32 Participants | 46 Participants | 48 Participants | 33 Participants | 48 Participants | 33 Participants | 35 Participants | 36 Participants | 40 Participants | 32 Participants | 35 Participants | 32 Participants | 29 Participants | 38 Participants | 34 Participants | 30 Participants | 34 Participants | 35 Participants | 1517 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 17 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 4 Participants | 2 Participants | 3 Participants | 0 Participants | 4 Participants | 1 Participants | 2 Participants | 4 Participants | 6 Participants | 3 Participants | 5 Participants | 4 Participants | 3 Participants | 4 Participants | 5 Participants | 6 Participants | 3 Participants | 7 Participants | 3 Participants | 3 Participants | 90 Participants |
| Race/Ethnicity, Customized Race Black or African American | 6 Participants | 5 Participants | 8 Participants | 6 Participants | 9 Participants | 7 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 6 Participants | 6 Participants | 13 Participants | 12 Participants | 7 Participants | 14 Participants | 12 Participants | 11 Participants | 16 Participants | 3 Participants | 11 Participants | 11 Participants | 14 Participants | 14 Participants | 7 Participants | 7 Participants | 12 Participants | 10 Participants | 7 Participants | 6 Participants | 10 Participants | 10 Participants | 9 Participants | 13 Participants | 7 Participants | 13 Participants | 9 Participants | 330 Participants |
| Race/Ethnicity, Customized Race Multiracial | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 14 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 14 Participants |
| Race/Ethnicity, Customized Race Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 48 Participants | 47 Participants | 46 Participants | 44 Participants | 44 Participants | 43 Participants | 46 Participants | 28 Participants | 45 Participants | 50 Participants | 27 Participants | 45 Participants | 38 Participants | 39 Participants | 43 Participants | 36 Participants | 37 Participants | 36 Participants | 37 Participants | 30 Participants | 41 Participants | 39 Participants | 22 Participants | 37 Participants | 29 Participants | 26 Participants | 25 Participants | 26 Participants | 25 Participants | 29 Participants | 26 Participants | 24 Participants | 24 Participants | 22 Participants | 22 Participants | 22 Participants | 29 Participants | 1277 Participants |
| Sex: Female, Male Female | 32 Participants | 30 Participants | 29 Participants | 29 Participants | 33 Participants | 30 Participants | 27 Participants | 16 Participants | 30 Participants | 30 Participants | 14 Participants | 28 Participants | 32 Participants | 23 Participants | 31 Participants | 29 Participants | 28 Participants | 28 Participants | 31 Participants | 17 Participants | 33 Participants | 31 Participants | 24 Participants | 30 Participants | 23 Participants | 20 Participants | 24 Participants | 18 Participants | 15 Participants | 22 Participants | 21 Participants | 22 Participants | 18 Participants | 23 Participants | 25 Participants | 22 Participants | 23 Participants | 941 Participants |
| Sex: Female, Male Male | 22 Participants | 23 Participants | 25 Participants | 22 Participants | 21 Participants | 22 Participants | 24 Participants | 17 Participants | 24 Participants | 24 Participants | 19 Participants | 25 Participants | 20 Participants | 32 Participants | 24 Participants | 24 Participants | 27 Participants | 27 Participants | 25 Participants | 20 Participants | 22 Participants | 24 Participants | 14 Participants | 24 Participants | 17 Participants | 19 Participants | 16 Participants | 24 Participants | 25 Participants | 18 Participants | 21 Participants | 19 Participants | 23 Participants | 17 Participants | 15 Participants | 18 Participants | 19 Participants | 802 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 | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk | EG032 affected / at risk | EG033 affected / at risk | EG034 affected / at risk | EG035 affected / at risk | EG036 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 53 | 0 / 54 | 0 / 53 | 0 / 54 | 0 / 52 | 0 / 52 | 0 / 33 | 0 / 54 | 0 / 54 | 0 / 33 | 0 / 53 | 0 / 52 | 0 / 56 | 0 / 56 | 0 / 56 | 0 / 55 | 0 / 56 | 0 / 56 | 0 / 37 | 0 / 55 | 0 / 56 | 0 / 38 | 0 / 56 | 0 / 41 | 0 / 40 | 0 / 40 | 0 / 42 | 0 / 40 | 0 / 40 | 0 / 42 | 0 / 42 | 0 / 41 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 42 |
| other Total, other adverse events | 1 / 54 | 3 / 53 | 4 / 54 | 3 / 51 | 1 / 54 | 6 / 52 | 3 / 51 | 2 / 33 | 0 / 55 | 6 / 53 | 0 / 33 | 0 / 53 | 1 / 52 | 3 / 55 | 2 / 55 | 2 / 53 | 2 / 55 | 7 / 56 | 1 / 55 | 2 / 37 | 4 / 56 | 8 / 54 | 5 / 38 | 2 / 54 | 2 / 40 | 0 / 39 | 2 / 40 | 0 / 42 | 3 / 40 | 3 / 40 | 1 / 42 | 5 / 41 | 1 / 41 | 5 / 40 | 2 / 40 | 4 / 40 | 2 / 42 |
| serious Total, serious adverse events | 2 / 54 | 2 / 53 | 1 / 54 | 1 / 51 | 2 / 54 | 1 / 52 | 2 / 51 | 0 / 33 | 1 / 55 | 1 / 53 | 1 / 33 | 1 / 53 | 1 / 52 | 2 / 55 | 1 / 55 | 0 / 53 | 0 / 55 | 1 / 56 | 0 / 55 | 1 / 37 | 1 / 56 | 0 / 54 | 1 / 38 | 2 / 54 | 1 / 40 | 1 / 39 | 1 / 40 | 0 / 42 | 0 / 40 | 1 / 40 | 0 / 42 | 1 / 41 | 0 / 41 | 0 / 40 | 0 / 40 | 1 / 40 | 0 / 42 |
Outcome results
Primary
Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Time frame: Day 29
Population: PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H3N2 Antibody | 2.8 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.7 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.7 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.6 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H3N2 Antibody | 2.6 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 2.3 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H1N1 Antibody | 3.5 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 2.0 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 2.1 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H1N1 Antibody | 3.7 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 2.4 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H3N2 Antibody | 3.4 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.4 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H3N2 Antibody | 1.8 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H1N1 Antibody | 1.8 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.3 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.4 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.2 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.6 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H3N2 Antibody | 1.9 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.7 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.7 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H3N2 Antibody | 2.3 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.6 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H3N2 Antibody | 2.0 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.0 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 2.1 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.6 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.5 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H1N1 Antibody | 1.9 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H3N2 Antibody | 1.7 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.3 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.5 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.6 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H3N2 Antibody | 2.3 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.7 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.5 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.3 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H3N2 Antibody | 1.8 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.4 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.7 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.9 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza A H3N2 Antibody | 2.7 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.6 ratio |
Primary
Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 \* LLOQ. Values greater than the upper limit of quantification (ULOQ) were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values for geometric mean (GM) titer, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Time frame: Day 29
Population: PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Victoria-lineage Antibody | 86.0 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H3N2 Antibody | 80.7 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Yamagata-lineage Antibody | 140.8 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H1N1 Antibody | 80.0 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H3N2 Antibody | 96.0 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H1N1 Antibody | 105.1 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Victoria-lineage Antibody | 80.7 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Yamagata-lineage Antibody | 122.8 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H3N2 Antibody | 155.6 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H1N1 Antibody | 129.0 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Victoria-lineage Antibody | 141.9 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Yamagata-lineage Antibody | 179.0 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Victoria-lineage Antibody | 75.8 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H1N1 Antibody | 73.9 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Yamagata-lineage Antibody | 80.7 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H3N2 Antibody | 65.8 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Victoria-lineage Antibody | 104.2 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H1N1 Antibody | 98.3 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H3N2 Antibody | 71.3 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Yamagata-lineage Antibody | 101.6 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H3N2 Antibody | 105.6 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Yamagata-lineage Antibody | 112.2 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Victoria-lineage Antibody | 108.4 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H1N1 Antibody | 111.2 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Yamagata-lineage Antibody | 112.2 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H3N2 Antibody | 79.3 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H1N1 Antibody | 99.9 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Victoria-lineage Antibody | 106.3 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H1N1 Antibody | 85.7 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H3N2 Antibody | 62.2 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Victoria-lineage Antibody | 98.5 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Yamagata-lineage Antibody | 94.3 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Victoria-lineage Antibody | 78.5 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H3N2 Antibody | 79.3 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H1N1 Antibody | 88.4 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Yamagata-lineage Antibody | 118.3 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H1N1 Antibody | 71.2 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Victoria-lineage Antibody | 75.9 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Yamagata-lineage Antibody | 97.7 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H3N2 Antibody | 75.2 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Yamagata-lineage Antibody | 98.3 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H1N1 Antibody | 106.0 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza B/Victoria-lineage Antibody | 82.0 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Influenza A H3N2 Antibody | 80.7 titer |
Primary
Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA)
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 arbitrary units (AU)/milliliter (mL) for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM concentration, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Time frame: Day 29
Population: PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) | 1567.0 AU/mL |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) | 1939.7 AU/mL |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) | 427.6 AU/mL |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) | 901.0 AU/mL |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) | 882.0 AU/mL |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) | 1108.3 AU/mL |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) | 679.7 AU/mL |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) | 878.7 AU/mL |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) | 904.8 AU/mL |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) | 1083.7 AU/mL |
Primary
Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Time frame: Day 29
Population: PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA | 5.4 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA | 9.1 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA | 3.3 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA | 5.4 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA | 4.4 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA | 3.6 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA | 4.5 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA | 4.1 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA | 7.1 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA | 8.0 ratio |
Primary
Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer. Arms based on the applicable vaccine for this Outcome Measure.
Time frame: Baseline to Day 29
Population: PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 15.8 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 42.1 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 31.6 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 21.1 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 15.8 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 26.3 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 36.8 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 50.0 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 27.0 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 43.2 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 51.4 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 27.0 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 17.9 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 7.7 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 7.7 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 12.8 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 9.5 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 9.5 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 31.0 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 23.8 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 12.5 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 30.0 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 12.5 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 27.5 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 23.1 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 7.7 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 25.6 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 23.1 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 17.5 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 17.5 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 12.5 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 15.0 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 2.6 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 34.2 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 13.2 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 21.1 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 9.1 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 21.2 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 30.3 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 9.1 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 4.8 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 11.9 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 35.7 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 42.9 percentage of participants |
Primary
Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 \* LLOQ if Baseline neutralizing antibody (nAb) level was \< LLOQ, or ≥4-fold rise if Baseline nAb level was ≥ LLOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. Arms based on the applicable vaccine for this Outcome Measure.
Time frame: Baseline to Day 29
Population: PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 55.0 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 57.9 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 33.3 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 52.4 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 47.5 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 33.3 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 50.0 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 44.7 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 63.6 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 69.0 percentage of participants |
Primary
Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Solicited ARs (local and systemic) were reported by participants an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills.
Time frame: Up to 7 days after study injection
Population: The solicited safety set included all randomized participants who receive the study intervention and contribute any solicited AR data. Participants were included in the vaccination group corresponding to what they actually received (as treated).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 32 Participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 36 Participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 37 Participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 43 Participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 42 Participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 31 Participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 44 Participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 26 Participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 42 Participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 46 Participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 29 Participants |
| Part 1 Cohort A7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 46 Participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 33 Participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 49 Participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 51 Participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 46 Participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 41 Participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 47 Participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 50 Participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 34 Participants |
| Part 1 Cohort B4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 46 Participants |
| Part 1 Cohort B5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 51 Participants |
| Part 1 Cohort B6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 38 Participants |
| Part 1 Cohort B7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 47 Participants |
| Part 2: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 32 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 32 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 39 Participants |
| Part 2: COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 40 Participants |
| Part 2: Investigational COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 34 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 34 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 39 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 3 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 37 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 4 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 38 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 1 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 33 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 2 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 34 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 3 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 37 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 4 | Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 39 Participants |
Primary
Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe 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. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Severity for all unsolicited AEs was determined by the Investigator based upon medical judgment and graded as Mild, Moderate or Severe. Number of participants with unsolicited AEs (SAEs and non-serious AEs) and severe AEs up to 28 days post-vaccination are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section.
Time frame: Up to 28 days after study injection
Population: The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 5 Participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 9 Participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 1 Participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 7 Participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 1 Participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 5 Participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 7 Participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 1 Participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 9 Participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 7 Participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 2 Participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 2 Participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 6 Participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 6 Participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 5 Participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort A7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 8 Participants |
| Part 1 Cohort A7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 5 Participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 11 Participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 8 Participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 9 Participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 8 Participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 11 Participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 6 Participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 6 Participants |
| Part 1 Cohort B4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort B4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 6 Participants |
| Part 1 Cohort B5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 8 Participants |
| Part 1 Cohort B5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort B6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 1 Cohort B6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 8 Participants |
| Part 1 Cohort B7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 5 Participants |
| Part 1 Cohort B7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 2: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 5 Participants |
| Part 2: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 1 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 3 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 6 Participants |
| Part 2: COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 4 Participants |
| Part 2: COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 1 Participants |
| Part 2: Investigational COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 4 Participants |
| Part 2: Investigational COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 4 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 3 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 3 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 4 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 4 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 6 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 5 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 4 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 5 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 4 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Unsolicited AEs | 8 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 4 | Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs | Severe AEs | 0 Participants |
Primary
Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs were protocol-defined medical concepts. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site. Number of participants with SAEs, AESIs, MAAEs, and AEs leading to study discontinuation up to Day 181 are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section.
Time frame: Day 1 through Day 181
Population: The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 3 Participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 11 Participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 2 Participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 16 Participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 2 Participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 1 Participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 2 Participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 13 Participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 16 Participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 2 Participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 2 Participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 13 Participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 1 Participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 20 Participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 2 Participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 2 Participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 12 Participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 0 Participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 4 Participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 1 Participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 12 Participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 14 Participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 1 Participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 7 Participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort A7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort A7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort A7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 1 Cohort A7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 10 Participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 1 Participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 13 Participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 2 Participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 13 Participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 1 Participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 13 Participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 0 Participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 17 Participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 2 Participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 0 Participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 17 Participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 2 Participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 15 Participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 1 Participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 0 Participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 10 Participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 9 Participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort B4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort B4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 1 Participants |
| Part 1 Cohort B4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort B4: mRNA-1083.2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 10 Participants |
| Part 1 Cohort B5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 13 Participants |
| Part 1 Cohort B5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 1 Cohort B5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort B5: mRNA-1083.2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 0 Participants |
| Part 1 Cohort B6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 1 Cohort B6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 12 Participants |
| Part 1 Cohort B6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 1 Cohort B6: mRNA-1083.2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 1 Cohort B7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 2 Participants |
| Part 1 Cohort B7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 2 Participants |
| Part 1 Cohort B7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 5 Participants |
| Part 1 Cohort B7: mRNA-1083.3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 2: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 8 Participants |
| Part 2: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 00 Participants |
| Part 2: Influenza Vaccine 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 7 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 1 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 2: Investigational Influenza Vaccine 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 6 Participants |
| Part 2: COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 2: COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 8 Participants |
| Part 2: COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 0 Participants |
| Part 2: COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: Investigational COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 8 Participants |
| Part 2: Investigational COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: Investigational COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 2: Investigational COVID-19 Vaccine 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 1 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 10 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 6 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 11 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 1 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 4 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 4 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 4 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 6 Participants |
| Part 2: mRNA-1083 Composition 1 Dose Level 4 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 11 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 1 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 10 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 2 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 9 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 3 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 1 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 4 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | SAEs | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 4 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 4 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | AESIs | 0 Participants |
| Part 2: mRNA-1083 Composition 2 Dose Level 4 | Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation | MAAEs | 8 Participants |
Secondary
Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ were replaced by 0.5 \* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 10 and ULOQ = 640 for Influenza A H1N1 and Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 320 for Influenza B/Victoria, and LLOQ = 10 and ULOQ = 640 for Influenza B/Yamagata antibody. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Time frame: Day 29 and Day 181
Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. Arms based on the applicable vaccine for this Outcome Measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 2.1 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 1.6 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 1.8 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 2.9 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.9 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.5 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 2.5 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 1.8 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 2.2 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.8 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.2 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 1.8 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 2.4 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 1.8 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.0 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.9 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.3 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 1.8 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 2.1 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.6 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 1.9 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 3.2 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.3 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.0 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 2.0 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 3.7 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 2.6 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 2.9 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.7 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 2.0 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 4.6 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 3.3 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 1.6 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 1.9 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.1 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.3 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 1.9 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 1.9 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.4 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 2.9 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.5 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 3.2 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.7 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.5 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 3.6 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 3.8 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 5.7 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.6 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 3.2 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 1.9 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.2 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.2 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.0 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 2.4 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 2.3 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.5 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.8 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 3.2 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.9 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.8 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.6 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 2.4 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 2.7 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.6 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.4 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.7 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.1 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 4.0 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 2.6 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 3.3 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 2.7 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 2.0 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 2.4 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.2 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 3.1 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.6 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.4 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 2.9 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.5 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 3.9 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 3.1 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 2.5 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.1 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.3 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 3.0 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.9 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.4 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.4 ratio |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 2.6 ratio |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.3 ratio |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.8 ratio |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 2.2 ratio |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 0.9 ratio |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 1.9 ratio |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.4 ratio |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 2.4 ratio |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.8 ratio |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.7 ratio |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 3.2 ratio |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.4 ratio |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.7 ratio |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 2.1 ratio |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 3.2 ratio |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 3.4 ratio |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.7 ratio |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 3.5 ratio |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.9 ratio |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 3.0 ratio |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.1 ratio |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.4 ratio |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 3.1 ratio |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.3 ratio |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.5 ratio |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.4 ratio |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 3.6 ratio |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.1 ratio |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 2.3 ratio |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 2.0 ratio |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 3.5 ratio |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.4 ratio |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.8 ratio |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 3.0 ratio |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.3 ratio |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 0.9 ratio |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 4.3 ratio |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.6 ratio |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.9 ratio |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 3.0 ratio |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 2.5 ratio |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 3.4 ratio |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 2.1 ratio |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 3.6 ratio |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.2 ratio |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.5 ratio |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 3.3 ratio |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 3.8 ratio |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 3.2 ratio |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 2.3 ratio |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.1 ratio |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 2.1 ratio |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 2.6 ratio |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.4 ratio |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 3.1 ratio |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.5 ratio |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.6 ratio |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 2.7 ratio |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.7 ratio |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 3.1 ratio |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 3.3 ratio |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 2.4 ratio |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.2 ratio |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 2.3 ratio |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 1.1 ratio |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 2.6 ratio |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 2.9 ratio |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 3.3 ratio |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 1.9 ratio |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 2.4 ratio |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 3.9 ratio |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 2.7 ratio |
Secondary
Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 strain included BA.4/5 and D614G antibody. Antibody values reported as below LLOQ were replaced by 0.5 \* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 53 and ULOQ = 71376 for SARS-CoV-2 BA.4/5 antibody and LLOQ = 74.1 and ULOQ = 184317 for SARS-CoV-2 D614G antibody. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Time frame: Day 29 and Day 181
Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. Arms based on the applicable vaccine for this Outcome Measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.7 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 4.8 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 7.3 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 2.5 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 10.0 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 4.1 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 2.5 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 5.6 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 7.5 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.7 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 4.2 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 3.2 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.6 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 4.0 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 9.6 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 4.4 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 2.5 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.2 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 2.6 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 5.7 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 2.4 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.7 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 4.1 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 6.8 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1.9 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 5.6 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.6 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 3.1 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.4 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 3.0 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1.7 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 4.7 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 6.9 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 3.5 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 4.5 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 2.0 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 10.9 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 4.4 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 2.5 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 5.8 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 6.1 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.5 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 2.8 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 3.2 ratio |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 2.7 ratio |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.5 ratio |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 3.6 ratio |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 6.9 ratio |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.4 ratio |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 2.7 ratio |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 7.4 ratio |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 4.2 ratio |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 4.3 ratio |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 7.3 ratio |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 3.1 ratio |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.7 ratio |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 3.5 ratio |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 3.8 ratio |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.4 ratio |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 8.4 ratio |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 3.6 ratio |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 5.3 ratio |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 10.3 ratio |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.5 ratio |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 6.9 ratio |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1.7 ratio |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 4.5 ratio |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 2.9 ratio |
Secondary
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ were replaced by 0.5 \* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 10 and ULOQ = 640 for Influenza A H1N1 and Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 320 for Influenza B/ Victoria, and LLOQ = 10 and ULOQ = 640 for Influenza B/Yamagata antibody. 95% CI was calculated based on t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Time frame: Baseline (Day 1), Day 29, and Day 181
Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. Arms based on the applicable vaccine for this Outcome Measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 75.2 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 55.4 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 85.1 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 104.5 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 61.8 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 100.7 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 34.4 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 94.8 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 167.2 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 78.4 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 49.0 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 49.7 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 47.5 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 112.0 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 67.7 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 49.2 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 110.0 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 87.2 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 56.5 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 34.1 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 104.7 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 128.2 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 85.7 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 106.3 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 84.5 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 46.7 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 100.4 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 116.9 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 55.0 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 62.9 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 108.5 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 95.1 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 99.3 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 38.9 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 88.3 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 88.3 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 148.1 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 46.8 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 55.7 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 113.2 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 30.7 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 151.5 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 149.3 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 139.9 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 98.9 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 108.1 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 146.7 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 52.7 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 104.3 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 90.7 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 140.6 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 110.8 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 58.2 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 109.6 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 43.1 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 80.6 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 129.8 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 141.2 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 95.8 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 73.1 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 52.2 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 63.5 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 178.8 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 104.3 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 128.5 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 119.8 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 31.7 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 145.6 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 41.4 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 109.6 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 101.9 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 196.4 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 72.5 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 74.5 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 112.3 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 55.1 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 64.8 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 106.0 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 91.5 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 174.5 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 29.0 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 127.3 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 148.0 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 98.9 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 55.0 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 56.5 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 98.1 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 142.5 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 114.2 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 103.4 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 53.1 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 37.6 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 135.3 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 139.5 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 155.5 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 98.7 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 39.6 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 183.7 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 104.2 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 80.0 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 107.2 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 87.3 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 48.4 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 39.1 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 152.9 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 46.8 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 94.6 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 82.7 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 129.1 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 172.7 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 185.7 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 57.7 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 32.1 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 100.6 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 117.9 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 140.2 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 69.6 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 121.9 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 90.6 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 145.2 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 83.2 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 48.3 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 118.4 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 27.5 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 88.4 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 114.0 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 64.5 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 34.5 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 83.4 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 103.2 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 78.3 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 151.4 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 48.3 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 61.8 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 111.2 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 81.3 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 145.3 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 111.5 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 165.9 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 59.1 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 140.6 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 33.1 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 94.1 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 91.8 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 176.7 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 43.9 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 48.9 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 174.5 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 115.9 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 140.0 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 117.8 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 138.2 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 85.5 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 83.8 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 31.5 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 121.4 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 37.6 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 126.4 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 129.4 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 105.6 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 38.9 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 129.8 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 134.5 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 100.1 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 76.8 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 185.0 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 51.4 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 115.9 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 30.0 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 120.8 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 96.7 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 126.3 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 102.1 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 121.4 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 178.0 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 147.9 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 73.0 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 91.1 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 57.3 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 39.0 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 149.3 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 36.0 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 34.3 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 157.9 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 89.0 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 135.9 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 82.2 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 59.4 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 75.7 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 81.6 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 145.3 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 104.8 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 112.2 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 116.3 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 177.6 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 76.1 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 52.7 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 86.0 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 154.5 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 32.0 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 35.3 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 74.7 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 176.3 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 120.8 titer |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 132.5 titer |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 93.8 titer |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 95.2 titer |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 113.1 titer |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 107.2 titer |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 88.5 titer |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 36.9 titer |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 43.0 titer |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 145.7 titer |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 181.5 titer |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 58.5 titer |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 142.9 titer |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 156.1 titer |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 33.0 titer |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 196.7 titer |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 91.2 titer |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 34.8 titer |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 111.7 titer |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 93.8 titer |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 99.9 titer |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 246.1 titer |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 77.0 titer |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 111.7 titer |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 101.1 titer |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 154.7 titer |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 150.5 titer |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 88.4 titer |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 110.8 titer |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 93.5 titer |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 39.4 titer |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 58.5 titer |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 161.2 titer |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 33.2 titer |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 134.1 titer |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 84.0 titer |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 112.3 titer |
Secondary
Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 strain included BA.4/5 and D614G antibody. Antibody values reported as below LLOQ were replaced by 0.5 \* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 53 and ULOQ = 71376 for SARS-CoV-2 BA.4/5 antibody and LLOQ = 74.1 and ULOQ = 184317 for SARS-CoV-2 D614G antibody. 95% CI was calculated based on t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Time frame: Baseline (Day 1), Day 29, and Day 181
Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. Arms based on the applicable vaccine for this Outcome Measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 3583.2 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 2052.1 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 9943.4 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 618.0 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 4536.9 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1500.1 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 5476.9 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 2176.0 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 574.1 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 12229.6 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 2524.4 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 5778.1 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1793.9 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 4006.2 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 616.9 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 4636.7 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 9275.7 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 2362.5 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 2578.4 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 585.9 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 5387.3 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 3927.0 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1851.8 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 10433.9 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 3706.0 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1461.3 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 2992.6 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 3317.4 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 646.6 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 7678.3 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 3877.3 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 3669.6 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 8513.1 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 536.3 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 2091.1 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1552.5 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 5647.8 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 10057.5 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 1008.2 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 2185.7 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 5622.0 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 3284.9 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 4120.6 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 8639.7 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 3889.4 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1480.3 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 883.2 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 2909.8 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 1548.5 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 2635.8 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1443.0 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 7038.1 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 3296.0 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 384.1 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 469.8 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 4743.9 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1972.1 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 1756.8 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 10243.2 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 4324.3 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 7431.1 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1595.9 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 3292.4 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 4005.9 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 653.7 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 2328.9 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 3061.1 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 440.5 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1225.0 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 1994.9 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 7127.4 titer |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 3008.6 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 1553.2 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 487.5 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 3599.0 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 6525.4 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1657.5 titer |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 2633.9 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 6738.9 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 3425.6 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 1575.1 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1413.4 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 469.1 titer |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 2743.1 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1792.7 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 4391.3 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 7844.9 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 524.8 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 2056.3 titer |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 2904.4 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1042.8 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 7333.0 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 3119.7 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 1391.3 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 1908.1 titer |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 301.8 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 1 | 489.8 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 6877.4 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 2386.0 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 1 | 1527.4 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 3458.4 titer |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 1270.3 titer |
Secondary
Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer \< 1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post vaccination HAI antibody titer. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Time frame: Baseline (Day 1) to Day 29, and Day 181
Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. Arms based on the applicable vaccine for this Outcome Measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 35.9 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 9.8 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 28.2 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 33.3 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 21.6 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 15.7 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 28.2 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 11.8 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 18.0 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 14.0 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 33.3 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 18.0 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 27.8 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 22.0 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 16.7 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 25.0 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 22.4 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 22.4 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 19.4 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 25.8 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 12.2 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 45.2 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 18.4 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 16.1 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 30.6 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 28.9 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 36.1 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 37.1 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 55.6 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 61.1 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 48.8 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 28.9 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 2.0 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 16.0 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 18.6 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 12.0 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 26.0 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 39.5 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 9.3 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 23.3 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 13.3 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 33.3 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 50.0 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 50.0 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 23.3 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 43.3 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 63.6 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 27.3 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 15.9 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 24.5 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 27.3 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 20.5 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 22.6 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 7.5 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 20.8 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 43.2 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 23.7 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 34.0 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 32.4 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 50.0 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 16.7 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 38.0 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 36.2 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 32.4 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 60.0 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 19.4 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 32.0 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 41.9 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 16.1 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 29.2 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 36.0 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 25.8 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 33.3 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 19.0 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 44.9 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 18.0 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 51.2 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 6.0 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 21.4 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 28.0 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 31.1 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 34.0 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 24.0 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 48.9 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 30.0 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 8.9 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 32.0 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 44.4 percentage of participants |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 13.0 percentage of participants |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 12.8 percentage of participants |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 30.8 percentage of participants |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 12.8 percentage of participants |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 33.3 percentage of participants |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 31.9 percentage of participants |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 27.7 percentage of participants |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 31.6 percentage of participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 18.2 percentage of participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 43.2 percentage of participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 38.5 percentage of participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 40.9 percentage of participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 40.4 percentage of participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 36.5 percentage of participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 47.7 percentage of participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 23.1 percentage of participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 16.0 percentage of participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 34.0 percentage of participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 20.0 percentage of participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 38.6 percentage of participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 30.0 percentage of participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 40.9 percentage of participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 47.7 percentage of participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 20.9 percentage of participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 38.6 percentage of participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 34.0 percentage of participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 15.9 percentage of participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 38.6 percentage of participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 21.2 percentage of participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 20.8 percentage of participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 24.5 percentage of participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 45.5 percentage of participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 36.0 percentage of participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 32.0 percentage of participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 0 percentage of participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 19.4 percentage of participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 44.4 percentage of participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 44.0 percentage of participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 38.9 percentage of participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 19.4 percentage of participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 20.0 percentage of participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 16.3 percentage of participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 48.0 percentage of participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 28.0 percentage of participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 44.0 percentage of participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 44.2 percentage of participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 46.5 percentage of participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 32.6 percentage of participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 35.4 percentage of participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 14.6 percentage of participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 52.1 percentage of participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 30.8 percentage of participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 38.5 percentage of participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 17.3 percentage of participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 29.2 percentage of participants |
| Part 1 Cohort B1: mRNA-1083.1 Dose Level 1 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 38.5 percentage of participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 40.7 percentage of participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 38.9 percentage of participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 29.6 percentage of participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 35.1 percentage of participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 29.7 percentage of participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 14.8 percentage of participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 32.4 percentage of participants |
| Part 1 Cohort B2: mRNA-1083.1 Dose Level 2 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 48.1 percentage of participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 11.4 percentage of participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 29 | 34.0 percentage of participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 45.5 percentage of participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 29 | 37.3 percentage of participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 37.8 percentage of participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 29 | 28.0 percentage of participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 52.3 percentage of participants |
| Part 1 Cohort B3: mRNA-1083.1 Dose Level 3 | Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 29 | 16.0 percentage of participants |
Secondary
Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
SARS-CoV-2 strain included BA.4/5 and D614G antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 x LLOQ if baseline nAb level was \<LLOQ, or ≥4 fold rise if baseline nAb level was ≥LLOQ. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Time frame: Baseline (Day 1) to Day 29, and Day 181
Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. Arms based on the applicable vaccine for this Outcome Measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 17.8 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 43.1 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 62.7 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 37.8 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 44.7 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 31.6 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 69.4 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 57.1 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 18.6 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 41.9 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 37.5 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 68.0 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 75.9 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 50.0 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 56.7 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 18.2 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 21.2 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 7.0 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 56.9 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 41.9 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 17.9 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 43.1 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 28.2 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 62.7 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 12.0 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 58.1 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 20.0 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 25.8 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 32.0 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 7.1 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 44.0 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 16.7 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 40.9 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 42.0 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 22.7 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 60.0 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 50.9 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 53.2 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 34.0 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 76.5 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 33.3 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 51.0 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 29.5 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 9.1 percentage of participants |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 39.6 percentage of participants |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 62.3 percentage of participants |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 31.8 percentage of participants |
| Part 1 Cohort A7: mRNA-1083.3 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 11.4 percentage of participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 32.0 percentage of participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 8.0 percentage of participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 58.3 percentage of participants |
| Part 1 Cohort B12: Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 41.7 percentage of participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 60.0 percentage of participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 42.0 percentage of participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 34.9 percentage of participants |
| Part 1 Cohort B11: Investigational Influenza Vaccine 2 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 23.3 percentage of participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 39.6 percentage of participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 12.5 percentage of participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 65.4 percentage of participants |
| Part 1 Cohort B8: Investigational Influenza Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 48.1 percentage of participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 68.4 percentage of participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 57.9 percentage of participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 3.6 percentage of participants |
| Part 1 Cohort B10: COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 42.9 percentage of participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 29 | 68.0 percentage of participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 BA.4/5 Antibody: Day 181 | 35.6 percentage of participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 29 | 42.0 percentage of participants |
| Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 | Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | SARS-CoV-2 D614G Antibody: Day 181 | 15.9 percentage of participants |
Secondary
Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 arbitrary units (AU)/milliliter (mL) for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM concentration, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Time frame: Baseline (Day 1), Day 181
Population: PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. 'Number analyzed' = participants evaluable for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 1 | 292.2 AU/mL |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 181 | 906.7 AU/mL |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 1 | 214.1 AU/mL |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 181 | 998.7 AU/mL |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 181 | 377.8 AU/mL |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 1 | 128.8 AU/mL |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 181 | 562.2 AU/mL |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 1 | 168.1 AU/mL |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 1 | 198.5 AU/mL |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 181 | 629.8 AU/mL |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 181 | 809.5 AU/mL |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 1 | 307.8 AU/mL |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 1 | 151.5 AU/mL |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 181 | 349.0 AU/mL |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 181 | 642.9 AU/mL |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 1 | 212.0 AU/mL |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 1 | 127.6 AU/mL |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 181 | 682.7 AU/mL |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 1 | 136.2 AU/mL |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA | SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 181 | 472 AU/mL |
Secondary
Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ replaced by 0.5 \* LLOQ. Values greater than ULOQ converted to ULOQ. LLOQ= 10, ULOQ= 3620 for Influenza A H1N1, LLOQ= 10, ULOQ= 5120 for Influenza A H3N2, LLOQ= 10, ULOQ= 1356 for Influenza B/Victoria-lineage, and LLOQ= 10, ULOQ= 1280 for Influenza B/Yamagata-lineage. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Time frame: Day 181
Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Arms based on the applicable vaccine for this Outcome Measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.2 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody | 2.0 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.3 ratio |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.9 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.6 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody | 3.2 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody | 1.9 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.4 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody | 2.1 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.1 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody | 3.1 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.3 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.1 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.1 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody | 1.7 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.3 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.0 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.1 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.1 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody | 1.4 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody | 2.0 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.2 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.2 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.9 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody | 1.4 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.3 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.2 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.4 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.0 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 0.9 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody | 1.4 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody | 1.7 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody | 3.7 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody | 2.0 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.2 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.2 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.2 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody | 1.8 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.3 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody | 2.8 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody | 1.8 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 1.1 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody | 3.0 ratio |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 1.2 ratio |
Secondary
Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Time frame: Day 181
Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Arms based on the applicable vaccine for this Outcome Measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | 3.3 ratio |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | 4.5 ratio |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | 2.8 ratio |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | 3.7 ratio |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | 3.4 ratio |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | 2.3 ratio |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | 2.5 ratio |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | 2.9 ratio |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | 4.7 ratio |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | 3.9 ratio |
Secondary
Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Time frame: Baseline (Day 1), Day 181
Population: PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. 'Number analyzed' = participants evaluable for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 30.4 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 54.2 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 81.6 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 28.8 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 110.8 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 50.9 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 49.8 titer |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 80.8 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 36.5 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 91.3 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 92.3 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 30.1 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 65.2 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 54.5 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 55.4 titer |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 41.0 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 84.7 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 64.9 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 46.0 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 108.5 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 108.4 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 60.4 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 100.7 titer |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 35.1 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 63.0 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 52.6 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 56.5 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 95.1 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 68.5 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 41.8 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 37.2 titer |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 64.1 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 70.8 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 52.6 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 64.6 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 70.1 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 73.0 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 44.9 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 93.1 titer |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 36.8 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 62.3 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 80.7 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 46.4 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 40.6 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 119.9 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 69.9 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 89.8 titer |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 69.7 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 69.4 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 49.9 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 82.6 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 61.7 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 39.6 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 50.8 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 111.9 titer |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 71.0 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 66.1 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 49.3 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 76.4 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 36.6 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 45.5 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 62.5 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 72.1 titer |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 60.8 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 32.7 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 56.0 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 63.0 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 35.2 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 73.6 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 73.3 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 108.4 titer |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 53.6 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 42.1 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 31.4 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 82.8 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 67.6 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 62.0 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 49.3 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 84.7 titer |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 82.9 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 181 | 52.4 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 181 | 56.6 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 1 | 63.0 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 1 | 37.1 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody: Day 181 | 63.0 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody: Day 1 | 48.7 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H1N1 Antibody: Day 181 | 101.5 titer |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay | Influenza A H3N2 Antibody: Day 1 | 30.2 titer |
Secondary
Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer. PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
Time frame: Baseline (Day 1) to Day 181
Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Arms based on the applicable vaccine for this Outcome Measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 45.5 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 9.1 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 30.3 percentage of participants |
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 12.1 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 50.0 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 29.4 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 8.8 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 8.8 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 36.4 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 24.2 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 6.1 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 9.1 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 19.4 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 22.2 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 5.6 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 5.6 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 8.8 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 2.9 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 11.8 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 23.5 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 5.6 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 25.0 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 2.8 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 36.1 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 25.0 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 9.4 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 9.4 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 15.6 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 26.3 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 10.5 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 10.5 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 2.6 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 6.3 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 34.4 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 40.6 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 12.5 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 26.7 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 6.7 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 10.0 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 40.0 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H1N1 Antibody | 43.8 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Yamagata-lineage Antibody | 0 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza B/Victoria-lineage Antibody | 6.3 percentage of participants |
| Part 1 Cohort A6: mRNA-1083.2 Dose Level 3 | Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A H3N2 Antibody | 28.1 percentage of participants |
Secondary
Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 \* LLOQ if Baseline nAb level was \< LLOQ, or ≥4-fold rise if Baseline nAb level was ≥ LLOQ. PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
Time frame: Baseline (Day 1) to Day 181
Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Arms based on the applicable vaccine for this Outcome Measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 Cohort A12: Influenza Vaccine 1 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 40.5 percentage of participants |
| Part 1 Cohort A13: Influenza Vaccine 2 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 43.3 percentage of participants |
| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 36.1 percentage of participants |
| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 32.4 percentage of participants |
| Part 1 Cohort A10: COVID-19 Vaccine 1 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 37.1 percentage of participants |
| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 25.0 percentage of participants |
| Part 1 Cohort A2: mRNA-1083.1 Dose Level 2 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 31.6 percentage of participants |
| Part 1 Cohort A3: mRNA-1083.1 Dose Level 3 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 28.1 percentage of participants |
| Part 1 Cohort A4: mRNA-1083.2 Dose Level 1 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 50.0 percentage of participants |
| Part 1 Cohort A5: mRNA-1083.2 Dose Level 2 | Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA | 50.0 percentage of participants |