SARS-CoV-2, Influenza
Conditions
Brief summary
The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.
Interventions
BIOLOGICALmRNA-1073
Sterile liquid for injection
BIOLOGICALmRNA-1010
Sterile liquid for injection
BIOLOGICALmRNA-1273
Sterile liquid for injection
BIOLOGICALPlacebo
0.9% sodium chloride (normal saline) injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) of 18 kilograms per meter squared (kg/m\^2) to 35 kg/m\^2 (inclusive) at the Screening Visit. * Participants must have been 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 the randomization visit (or less per local guidance).
Exclusion criteria
* Participant is acutely ill or febrile (temperature ≥ 38.0℃ \[100.4°F\]) 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day Screening window and will retain their initially assigned participant number. * Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication ≤ 60 days prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition. Asymptomatic conditions and conditions with no evidence of end organ involvement (for example, mild hypertension, dyslipidemia) are not exclusionary, provided that they are being appropriately managed and are clinically stable (for example, unlikely to result in symptomatic illness within the time course of this study). Illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (for example, immune-modifying treatments), at the discretion of the investigator. * Participant has a reported history of congenital or acquired immunodeficiency, immunosuppressive condition, or immune-mediated disease. * Participant has dermatologic conditions that could affect local solicited adverse reaction (AR) assessments (for example, tattoos, psoriasis patches affecting skin over the deltoid areas). * Participant has a reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine(s) or any components of the mRNA vaccines. * Participant has a reported history of bleeding disorder that is considered a contraindication to IM injection or phlebotomy. * Participant has a diagnosis of malignancy within previous 10 years (excluding nonmelanoma skin cancer). * Participant has 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 study or could interfere with the interpretation of study results. * Participant has received systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to Screening (for corticosteroids ≥ 10 mg/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, topical steroids are not exclusionary. * Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤ 28 days prior to study injections (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days before or after the study injections. * Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤ 180 days prior to the randomization visit. * Participant has tested positive for influenza by local health authority approved testing methods ≤ 180 days prior to the Screening Visit. * Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the US CDC in the past 10 days prior to the Screening Visit. * Participant has known history of SARS-CoV-2 infection within ≤ 90 days. * Participant has received systemic immunoglobulins or blood products ≤ 90 days prior to the Screening Visit or plans to receive systemic immunoglobulins or blood products during the study. * Participant has a history of myocarditis, pericarditis, or myopericarditis. * Participant has donated ≥ 450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study. * Participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study. * Participant is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel. Phase 1 Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Up to Day 8 (7 days post vaccination) | Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Note, that not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of all serious AEs (SAEs) and all nonserious AEs (Other), regardless of causality, is in Reported Adverse Events section. |
| Number of Participants With Unsolicited Adverse Events (AEs) | Up to Day 29 (28 days post vaccination) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs (Other) reported up to the end of the study, regardless of causality, is located in the Reported Adverse Events section. |
| Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | Up to Day 181 | An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. This would include visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). A summary of SAEs and all nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2 | Day 29 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. |
| Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Day 29 | Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included BV and BY. |
| Percentage of Participants With Seroresponse as Measured by PsVNA (or Binding Antibody Assay) For SARS-CoV-2 | Day 29 | Seroresponse at a participant level is defined as an increase from below the lower limit of quantification (LLOQ) to \>= 4 x LLOQ if baseline neutralizing antibody (nAb) level is \< LLOQ, or \>= 4 fold rise if baseline nAb level is \>=LLOQ. |
| Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Day 29 | Seroconversion at a participant level is 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. |
| Geometric Mean Titer of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | Day 29 | — |
| Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Day 29 | Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included BV and BY. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| mRNA-1273 + Placebo On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm. | 49 |
| mRNA-1010 + Placebo On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm. | 99 |
| mRNA-1010 + mRNA-1273 On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm. | 101 |
| Dose A: mRNA-1073 Low Dose + Placebo On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm. | 100 |
| Dose B: mRNA-1073 Medium Dose + Placebo On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm. | 98 |
| Dose C: mRNA-1073 High Dose + Placebo On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm. | 100 |
| Total | 547 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 7 | 0 | 4 | 2 | 3 |
| Overall Study | Other | 0 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 3 | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | mRNA-1273 + Placebo | mRNA-1010 + Placebo | mRNA-1010 + mRNA-1273 | Dose A: mRNA-1073 Low Dose + Placebo | Dose B: mRNA-1073 Medium Dose + Placebo | Dose C: mRNA-1073 High Dose + Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 15.37 | 47.4 years STANDARD_DEVIATION 14.49 | 48.5 years STANDARD_DEVIATION 14.55 | 49.3 years STANDARD_DEVIATION 15.1 | 49.0 years STANDARD_DEVIATION 13.93 | 48.2 years STANDARD_DEVIATION 14.54 | 48.4 years STANDARD_DEVIATION 14.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 11 Participants | 14 Participants | 11 Participants | 8 Participants | 7 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 88 Participants | 85 Participants | 88 Participants | 88 Participants | 92 Participants | 483 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 5 Participants | 3 Participants | 4 Participants | 3 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 13 Participants | 8 Participants | 17 Participants | 16 Participants | 13 Participants | 78 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 37 Participants | 83 Participants | 85 Participants | 79 Participants | 76 Participants | 83 Participants | 443 Participants |
| Sex: Female, Male Female | 29 Participants | 54 Participants | 65 Participants | 55 Participants | 56 Participants | 64 Participants | 323 Participants |
| Sex: Female, Male Male | 20 Participants | 45 Participants | 36 Participants | 45 Participants | 42 Participants | 36 Participants | 224 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 99 | 0 / 101 | 0 / 100 | 0 / 98 | 0 / 100 |
| other Total, other adverse events | 42 / 49 | 86 / 99 | 93 / 101 | 94 / 100 | 81 / 98 | 89 / 100 |
| serious Total, serious adverse events | 2 / 49 | 1 / 99 | 0 / 101 | 0 / 100 | 1 / 98 | 0 / 100 |
Outcome results
Primary
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. This would include visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). A summary of SAEs and all nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section.
Time frame: Up to Day 181
Population: The safety set consisted of all randomly assigned participants who received the IP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mRNA-1273 + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | SAEs | 2 Participants |
| mRNA-1273 + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | AESIs | 0 Participants |
| mRNA-1273 + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | MAAEs | 13 Participants |
| mRNA-1273 + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | AEs leading to discontinuation | 0 Participants |
| mRNA-1010 + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | MAAEs | 38 Participants |
| mRNA-1010 + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | AESIs | 2 Participants |
| mRNA-1010 + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | SAEs | 1 Participants |
| mRNA-1010 + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | AEs leading to discontinuation | 0 Participants |
| mRNA-1010 + mRNA-1273 | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | AEs leading to discontinuation | 0 Participants |
| mRNA-1010 + mRNA-1273 | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | MAAEs | 32 Participants |
| mRNA-1010 + mRNA-1273 | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | AESIs | 0 Participants |
| mRNA-1010 + mRNA-1273 | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | SAEs | 0 Participants |
| Dose A: mRNA-1073 Low Dose + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | SAEs | 0 Participants |
| Dose A: mRNA-1073 Low Dose + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | AEs leading to discontinuation | 0 Participants |
| Dose A: mRNA-1073 Low Dose + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | AESIs | 1 Participants |
| Dose A: mRNA-1073 Low Dose + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | MAAEs | 34 Participants |
| Dose B: mRNA-1073 Medium Dose + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | MAAEs | 34 Participants |
| Dose B: mRNA-1073 Medium Dose + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | AEs leading to discontinuation | 0 Participants |
| Dose B: mRNA-1073 Medium Dose + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | AESIs | 0 Participants |
| Dose B: mRNA-1073 Medium Dose + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | SAEs | 1 Participants |
| Dose C: mRNA-1073 High Dose + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | AESIs | 1 Participants |
| Dose C: mRNA-1073 High Dose + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | MAAEs | 44 Participants |
| Dose C: mRNA-1073 High Dose + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | AEs leading to discontinuation | 0 Participants |
| Dose C: mRNA-1073 High Dose + Placebo | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation | SAEs | 0 Participants |
Primary
Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs)
Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Note, that not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of all serious AEs (SAEs) and all nonserious AEs (Other), regardless of causality, is in Reported Adverse Events section.
Time frame: Up to Day 8 (7 days post vaccination)
Population: The solicited safety set consisted of all participants in the safety set who contributed any solicited AR data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mRNA-1273 + Placebo | Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Solicited Local ARs | 38 Participants |
| mRNA-1273 + Placebo | Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Solicited Systemic ARs | 31 Participants |
| mRNA-1010 + Placebo | Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Solicited Local ARs | 80 Participants |
| mRNA-1010 + Placebo | Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Solicited Systemic ARs | 70 Participants |
| mRNA-1010 + mRNA-1273 | Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Solicited Local ARs | 90 Participants |
| mRNA-1010 + mRNA-1273 | Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Solicited Systemic ARs | 87 Participants |
| Dose A: mRNA-1073 Low Dose + Placebo | Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Solicited Local ARs | 92 Participants |
| Dose A: mRNA-1073 Low Dose + Placebo | Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Solicited Systemic ARs | 80 Participants |
| Dose B: mRNA-1073 Medium Dose + Placebo | Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Solicited Local ARs | 76 Participants |
| Dose B: mRNA-1073 Medium Dose + Placebo | Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Solicited Systemic ARs | 63 Participants |
| Dose C: mRNA-1073 High Dose + Placebo | Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Solicited Local ARs | 78 Participants |
| Dose C: mRNA-1073 High Dose + Placebo | Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) | Solicited Systemic ARs | 67 Participants |
Primary
Number of Participants With Unsolicited Adverse Events (AEs)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs (Other) reported up to the end of the study, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Up to Day 29 (28 days post vaccination)
Population: The safety set consisted of all randomly assigned participants who received the IP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mRNA-1273 + Placebo | Number of Participants With Unsolicited Adverse Events (AEs) | 7 Participants |
| mRNA-1010 + Placebo | Number of Participants With Unsolicited Adverse Events (AEs) | 21 Participants |
| mRNA-1010 + mRNA-1273 | Number of Participants With Unsolicited Adverse Events (AEs) | 14 Participants |
| Dose A: mRNA-1073 Low Dose + Placebo | Number of Participants With Unsolicited Adverse Events (AEs) | 19 Participants |
| Dose B: mRNA-1073 Medium Dose + Placebo | Number of Participants With Unsolicited Adverse Events (AEs) | 11 Participants |
| Dose C: mRNA-1073 High Dose + Placebo | Number of Participants With Unsolicited Adverse Events (AEs) | 22 Participants |
Secondary
Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included BV and BY.
Time frame: Day 29
Population: Per protocol set consisted of all participants in the FAS who comply with injection schedule, comply with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment and a Day 29 assessment, do not have influenza or SARS-CoV-2 infection at baseline and post-baseline up to Day 29 and have no major protocol deviations and/or prohibited concomitant medication use that are prespecified with impacts on immune response. N=number evaluable for this endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| mRNA-1273 + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 3.97 ratio |
| mRNA-1273 + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 5.82 ratio |
| mRNA-1273 + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 1.61 ratio |
| mRNA-1273 + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 2.68 ratio |
| mRNA-1010 + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 3.31 ratio |
| mRNA-1010 + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 2.17 ratio |
| mRNA-1010 + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 5.07 ratio |
| mRNA-1010 + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 1.64 ratio |
| mRNA-1010 + mRNA-1273 | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 1.63 ratio |
| mRNA-1010 + mRNA-1273 | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 3.84 ratio |
| mRNA-1010 + mRNA-1273 | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 1.29 ratio |
| mRNA-1010 + mRNA-1273 | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 2.25 ratio |
| Dose A: mRNA-1073 Low Dose + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 2.48 ratio |
| Dose A: mRNA-1073 Low Dose + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 4.15 ratio |
| Dose A: mRNA-1073 Low Dose + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 1.65 ratio |
| Dose A: mRNA-1073 Low Dose + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 1.29 ratio |
| Dose B: mRNA-1073 Medium Dose + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 1.58 ratio |
| Dose B: mRNA-1073 Medium Dose + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 1.29 ratio |
| Dose B: mRNA-1073 Medium Dose + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 3.41 ratio |
| Dose B: mRNA-1073 Medium Dose + Placebo | Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 2.67 ratio |
Secondary
Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
Time frame: Day 29
Population: Per protocol set consisted of all participants in the FAS who comply with injection schedule, comply with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment and a Day 29 assessment, do not have influenza or SARS-CoV-2 infection at baseline and post-baseline up to Day 29 and have no major protocol deviations and/or prohibited concomitant medication use that are prespecified with impacts on immune response. N=number evaluable for this endpoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| mRNA-1273 + Placebo | Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2 | 6.14 ratio |
| mRNA-1010 + Placebo | Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2 | 4.07 ratio |
| mRNA-1010 + mRNA-1273 | Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2 | 3.50 ratio |
| Dose A: mRNA-1073 Low Dose + Placebo | Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2 | 3.45 ratio |
| Dose B: mRNA-1073 Medium Dose + Placebo | Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2 | 3.18 ratio |
Secondary
Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included BV and BY.
Time frame: Day 29
Population: Per protocol set consisted of all participants in the FAS who comply with injection schedule, comply with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment and a Day 29 assessment, do not have influenza or SARS-CoV-2 infection at baseline and post-baseline up to Day 29 and have no major protocol deviations and/or prohibited concomitant medication use that are prespecified with impacts on immune response. N=number evaluable for this endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| mRNA-1273 + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 175.41 titer |
| mRNA-1273 + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 189.9 titer |
| mRNA-1273 + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 106.22 titer |
| mRNA-1273 + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 194.51 titer |
| mRNA-1010 + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 134.04 titer |
| mRNA-1010 + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 182.01 titer |
| mRNA-1010 + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 214.12 titer |
| mRNA-1010 + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 107.91 titer |
| mRNA-1010 + mRNA-1273 | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 139.48 titer |
| mRNA-1010 + mRNA-1273 | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 144.36 titer |
| mRNA-1010 + mRNA-1273 | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 91.78 titer |
| mRNA-1010 + mRNA-1273 | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 104.78 titer |
| Dose A: mRNA-1073 Low Dose + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 111.33 titer |
| Dose A: mRNA-1073 Low Dose + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 141.15 titer |
| Dose A: mRNA-1073 Low Dose + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 130.27 titer |
| Dose A: mRNA-1073 Low Dose + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 89.27 titer |
| Dose B: mRNA-1073 Medium Dose + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 121.29 titer |
| Dose B: mRNA-1073 Medium Dose + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 84.82 titer |
| Dose B: mRNA-1073 Medium Dose + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 129.94 titer |
| Dose B: mRNA-1073 Medium Dose + Placebo | Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 108.68 titer |
Secondary
Geometric Mean Titer of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Time frame: Day 29
Population: Per protocol set consisted of all participants in the FAS who comply with injection schedule, comply with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment and a Day 29 assessment, do not have influenza or SARS-CoV-2 infection at baseline and post-baseline up to Day 29 and have no major protocol deviations and/or prohibited concomitant medication use that are prespecified with impacts on immune response. N=number evaluable for this endpoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| mRNA-1273 + Placebo | Geometric Mean Titer of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | 8477.30 titer |
| mRNA-1010 + Placebo | Geometric Mean Titer of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | 6075.76 titer |
| mRNA-1010 + mRNA-1273 | Geometric Mean Titer of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | 7573.97 titer |
| Dose A: mRNA-1073 Low Dose + Placebo | Geometric Mean Titer of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | 5678.54 titer |
| Dose B: mRNA-1073 Medium Dose + Placebo | Geometric Mean Titer of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | 4410.29 titer |
Secondary
Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains
Seroconversion at a participant level is 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.
Time frame: Day 29
Population: Per protocol set consisted of all participants in the FAS who comply with injection schedule, comply with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment and a Day 29 assessment, do not have influenza or SARS-CoV-2 infection at baseline and post-baseline up to Day 29 and have no major protocol deviations and/or prohibited concomitant medication use that are prespecified with impacts on immune response. N=number evaluable for this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mRNA-1273 + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 47.1 percentage of participants |
| mRNA-1273 + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 64.4 percentage of participants |
| mRNA-1273 + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 16.1 percentage of participants |
| mRNA-1273 + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 32.2 percentage of participants |
| mRNA-1010 + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 42.6 percentage of participants |
| mRNA-1010 + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 19.1 percentage of participants |
| mRNA-1010 + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 63.8 percentage of participants |
| mRNA-1010 + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 9.6 percentage of participants |
| mRNA-1010 + mRNA-1273 | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 11.0 percentage of participants |
| mRNA-1010 + mRNA-1273 | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 53.8 percentage of participants |
| mRNA-1010 + mRNA-1273 | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 3.3 percentage of participants |
| mRNA-1010 + mRNA-1273 | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 27.5 percentage of participants |
| Dose A: mRNA-1073 Low Dose + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 31.4 percentage of participants |
| Dose A: mRNA-1073 Low Dose + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 53.5 percentage of participants |
| Dose A: mRNA-1073 Low Dose + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 10.5 percentage of participants |
| Dose A: mRNA-1073 Low Dose + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 2.3 percentage of participants |
| Dose B: mRNA-1073 Medium Dose + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BY Antibody | 10.5 percentage of participants |
| Dose B: mRNA-1073 Medium Dose + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza B BV Antibody | 6.3 percentage of participants |
| Dose B: mRNA-1073 Medium Dose + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H3N2 Antibody | 42.1 percentage of participants |
| Dose B: mRNA-1073 Medium Dose + Placebo | Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains | Influenza A H1N1 Antibody | 31.6 percentage of participants |
Secondary
Percentage of Participants With Seroresponse as Measured by PsVNA (or Binding Antibody Assay) For SARS-CoV-2
Seroresponse at a participant level is defined as an increase from below the lower limit of quantification (LLOQ) to \>= 4 x LLOQ if baseline neutralizing antibody (nAb) level is \< LLOQ, or \>= 4 fold rise if baseline nAb level is \>=LLOQ.
Time frame: Day 29
Population: Per protocol set consisted of all participants in the FAS who comply with injection schedule, comply with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment and a Day 29 assessment, do not have influenza or SARS-CoV-2 infection at baseline and post-baseline up to Day 29 and have no major protocol deviations and/or prohibited concomitant medication use that are prespecified with impacts on immune response. N=number evaluable for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mRNA-1273 + Placebo | Percentage of Participants With Seroresponse as Measured by PsVNA (or Binding Antibody Assay) For SARS-CoV-2 | 52.4 percentage of participants |
| mRNA-1010 + Placebo | Percentage of Participants With Seroresponse as Measured by PsVNA (or Binding Antibody Assay) For SARS-CoV-2 | 44.4 percentage of participants |
| mRNA-1010 + mRNA-1273 | Percentage of Participants With Seroresponse as Measured by PsVNA (or Binding Antibody Assay) For SARS-CoV-2 | 37.5 percentage of participants |
| Dose A: mRNA-1073 Low Dose + Placebo | Percentage of Participants With Seroresponse as Measured by PsVNA (or Binding Antibody Assay) For SARS-CoV-2 | 36.5 percentage of participants |
| Dose B: mRNA-1073 Medium Dose + Placebo | Percentage of Participants With Seroresponse as Measured by PsVNA (or Binding Antibody Assay) For SARS-CoV-2 | 35.9 percentage of participants |