A Study of mRNA-1345 Vaccine Targeting Respiratory Syncyt... | NCT05330975 | Trialant
NCT05330975
Sponsor
ModernaTX, Inc.
Status
Completed
Last Update Posted
Dec 30, 2025Actual
Enrollment
3,317Actual
Phase
Phase 3
Conditions
Respiratory Syncytial Virus
Interventions
Placebo
mRNA-1345
Afluria® Quadrivalent
mRNA-1273.214
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05330975
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
mRNA-1345-P302
Secondary IDs
Not provided
Brief Title
A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age
Official Title
A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered With a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given as an Open-label Boost at 1 Year Following a Primary Dose in Adults ≥ 50 Years of Age
Acronym
RSVictory
Organization
ModernaTX, Inc.INDUSTRY
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 1, 2022Actual
Primary Completion Date
Nov 8, 2024Actual
Completion Date
Nov 8, 2024Actual
First Submitted Date
Apr 8, 2022
First Submission Date that Met QC Criteria
Apr 8, 2022
First Posted Date
Apr 15, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Nov 7, 2025
Results First Submitted that Met QC Criteria
Dec 9, 2025
Results First Posted Date
Dec 30, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 9, 2025
Last Update Posted Date
Dec 30, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ModernaTX, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza.
The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose.
Detailed Description
Not provided
Conditions Module
Conditions
Respiratory Syncytial Virus
Keywords
Viral Diseases
Messenger RNA
Moderna
mRNA-1345
Respiratory syncytial virus
Safety
Vaccines
SARS-CoV-2
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
3,317Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: mRNA-1345 + Placebo
Experimental
Single injection of mRNA-1345 and placebo, administered intramuscularly (IM), one in each arm on Day 1.
Biological: Placebo
Biological: mRNA-1345
Part A: mRNA-1345 + Afluria® Quadrivalent
Experimental
Single injection of mRNA-1345 and Afluria® quadrivalent, administered IM, one in each arm on Day 1.
Biological: mRNA-1345
Biological: Afluria® Quadrivalent
Part A: Afluria® Quadrivalent + Placebo
Active Comparator
Single injection of Afluria® quadrivalent and placebo, administered IM, one in each arm on Day 1.
Biological: Placebo
Biological: Afluria® Quadrivalent
Part B: mRNA-1345 + Placebo
Experimental
Single injection of mRNA-1345 and placebo, administered IM, one in each arm on Day 1. An additional injection of mRNA-1273.214, administered on Day 29.
Biological: Placebo
Biological: mRNA-1345
Biological: mRNA-1273.214
Part B: mRNA-1345 + mRNA-1273.214
Experimental
Single injection of mRNA-1345 and mRNA-1273.214, administered IM, one in each arm on Day 1. An additional injection of placebo administered on Day 29.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Biological
0.9% sodium chloride (normal saline) injection
Part A: Afluria® Quadrivalent + Placebo
Part A: mRNA-1345 + Placebo
Part B: mRNA-1273.214 + Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Within 7 days after Day 1 injection
Part A: Number of Participants With Unsolicited Adverse Events (AEs) After Day 1 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. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 through Day 28 (28 days after Day 1 injection)
Part A: Number of Participants With Medically Attended AEs (MAAEs), SAEs, Adverse Events of Special Interest (AESIs), and AEs Leading to Withdrawal
A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. 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, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Secondary Outcomes
Measure
Description
Time Frame
Part A: GMT of Serum RSV-B NAbs at Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Day 29
Other Outcomes
Measure
Description
Time Frame
Number of Deaths During the Study
A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable and/or the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Parts A and B both:
Adults ≥50 years of age on the day of the Randomization Visit (Day 1) who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by: Absence of changes in medical therapy within 1 month due to treatment failure or toxicity; Absence of medical events qualifying as SAEs within 1 month of the planned vaccination on Day 1; and absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator, would make completion of the protocol unlikely.
Able to comply with study requirements, including access to transportation for study visits.
Part B only:
Fully vaccinated for COVID-19 with an approved primary series according to the locally authorized or approved regimen. If the most recent COVID-19 vaccine was part of a primary series, it must be ≥ 150 days before (or less per local guidance) Day 1. If the most recent COVID-19 vaccine was a booster dose, it must be ≥ 120 days before (or less per local guidance) Day 1.
Part C:
Participants at Part C study sites who have been enrolled in Part B (Groups 4 and 5) of this study; have immunogenicity blood sampling at Part B baseline and Day 29; completed the Day 211/end-of-study visits for Part B; were included in the per-protocol (PP) set; and received 1 dose of mRNA-1345 at least 12 months (but no later than 15 months) prior to the time of enrollment.
Able to comply with study requirements, including access to transportation for study visits.
Key Exclusion Criteria:
Part A:
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 after the study injections.
Prior participation in research involving receipt of any investigational product (drug/biologic/device including any investigational RSV product) within 45 days before the planned date of the Day 1 study injection.
Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤180 days prior to the Randomization Visit (Day 1).
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.
Part B:
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 after the study injections (with the exception of SARS-Cov-2 vaccination).
Prior participation in research involving receipt of any investigational product (drug/biologic/device with the exception of RSV investigation products) within 45 days before the planned date of the Day 1 study injection.
Prior receipt of any investigational/approved RSV product within 1 year of the Day 1 study injection.
Has known history of SARS-CoV-2 infection within 90 days prior to enrollment.
Parts A and B both:
Participant had significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 10 days, as defined by the United States (US) Centers for Disease Control and Prevention (CDC) as a close contact of someone who has had COVID-19.
Part C:
Participation in another interventional clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of the BD Day 1 study injection. Any prior receipt of an investigational or approved vaccine against RSV, except as part of mRNA-1345 Study P302 Part B, is exclusionary.
Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to the study injection (BD Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
Goswami J, Cardona JF, Caso J, Hsu DC, Simorellis AK, Wilson L, Dhar R, Wang X, Kapoor A, Collins A, Righi V, Lan L, Du J, Zhou H, Stoszek SK, Shaw CA, Reuter C, Wilson E, Das R. Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345, an mRNA Vaccine Against Respiratory Syncytial Virus, Administered 12 Months Following a Primary Dose in Adults Aged >/=50 Years. Clin Infect Dis. 2026 Apr 30;82(4):e855-e862. doi: 10.1093/cid/ciaf515.
Single injection of mRNA-1273.214 and placebo, administered IM, one in each arm on Day 1. An additional injection of placebo administered on Day 29.
Biological: Placebo
Biological: mRNA-1273.214
Part C: mRNA-1345
Experimental
Single injection of mRNA-1345 administered IM on BD Day 1.
Biological: mRNA-1345
Part B: mRNA-1345 + Placebo
Part B: mRNA-1345 + mRNA-1273.214
mRNA-1345
Biological
Sterile liquid for injection
Part A: mRNA-1345 + Afluria® Quadrivalent
Part A: mRNA-1345 + Placebo
Part B: mRNA-1345 + Placebo
Part B: mRNA-1345 + mRNA-1273.214
Part C: mRNA-1345
Afluria® Quadrivalent
Biological
single-dose, pre-filled syringe for injection
Part A: Afluria® Quadrivalent + Placebo
Part A: mRNA-1345 + Afluria® Quadrivalent
mRNA-1273.214
Biological
Sterile liquid for injection
Part B: mRNA-1273.214 + Placebo
Part B: mRNA-1345 + Placebo
Part B: mRNA-1345 + mRNA-1273.214
Day 1 through Day 181 (end of Study Part A)
Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) Neutralizing Antibodies (NAbs) at Day 29
Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 international units (IU)/milliliter (mL) and ULOQ was 259061 IU/mL for RSV-A. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Day 29
Part A: Percentage of Participants With Seroresponse in RSV-A NAbs at Day 29
Seroresponse was defined as ≥4 × lower limit of quantification (LLOQ) if baseline was \
Day 29
Part A: GMT of Serum Anti-hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29
Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.
Day 29
Part B: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 1 Injection
Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Within 7 days after Day 1 injection
Part B: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 29 Injection
Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Within 7 days after Day 29 injection
Part B: Number of Participants With Unsolicited AEs After Day 1 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 PT/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. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 through Day 28 (28 days after Day 1 injection)
Part B: Number of Participants With Unsolicited AEs After Day 29 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. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 29 through Day 57 (28 days after Day 29 injection)
Part B: Number of Participants With MAAEs, SAEs, AESIs, and AEs Leading to Withdrawal
A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. 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, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 through Day 211
Part B: GMT of Serum RSV-A at Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Day 29
Part B: Percentage of Participants With Seroresponse for RSV-A Neutralizing Abs From Baseline to Day 29
Seroresponse was defined as ≥4 × LLOQ if baseline was \
Baseline to Day 29
Part B: Geometric Mean Concentration (GMC) of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 29
The model-based GM titer was estimated on ANCOVA model. SARS-CoV-2 variants included Wuhan-Hu-1 and B.1.1.529. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 arbitrary units (AU)/milliliters (mL) and ULOQ was 111433 AU/mL for Wuhan-Hu-1. LLOQ was 8 and ULOQ was B.1.1.529 for B1.1.529. As prespecified, only arms where participants received mRNA-1273.214 are presented for this outcome measure.
Day 29
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs From Baseline to Day 29
Seroresponse was defined as ≥4 × LLOQ if baseline was \
Baseline to Day 29
Part C: Number of Participants With Solicited Local and Systemic Within 7 Days After Revaccination Day 1
Solicited ARs were collected in an electronic eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Within 7 days after Day 1 revaccination
Part C: Number of Participants With Unsolicited AEs Within 28 Days After Revaccination Day 1
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 PT/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. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Revaccination Day 1 through Day 28 (28 days after revaccination Day 1)
Part C: Number of Participants With MAAEs
A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner.
Revaccination Day 1 through Day 181
Part C: Number of Participants With SAEs, AESIs, and AEs Leading to Withdrawal
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, was a congenital anomaly/birth defect, or was an important medical event. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Revaccination Day 1 through Day 361
Part C: GMT of Serum RSV-A and RSV-B NAbs mRNA-1345 Revaccination Day 29 Compared to Primary Vaccination Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 IU/mL for RSV-B.
mRNA-1345 Revaccination Day 29 and mRNA-1345 primary vaccination Day 29 (received in Part B) are presented.
Primary Vaccination Day 29 to Revaccination Day 29
Part A: Percentage of Participants With Seroresponse in RSV-B NAbs at Day 29
Seroresponse was defined as ≥4 × LLOQ if baseline was \
Day 29
Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains at Day 181
Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Seroconversion was defined as a titer ≥1:40 if baseline was <1:10 or a 4-fold or greater rise from baseline in the titers if Baseline was ≥1:10. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.
Day 181
Part A: GMT of Serum RSV-A and RSV-B NAbs at Day 181
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Day 181
Part A: Geometric Mean Fold Rise (GMFR) of Serum RSV-A and RSV-B NAbs at Day 181
95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Day 181
Part A: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 181
Seroresponse was defined as ≥4 × LLOQ if baseline was \
Day 181
Part A: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 181
≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 * LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Baseline to Day 181
Part A: GMT of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181
Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.
Day 181
Part A: GMFR of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181
Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B. 95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.
Day 181
Part B: GMT of Serum RSV-B NAbs at Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Day 29
Part B: Percentage of Participants With Seroresponse in RSV-B NAbs From Baseline to Day 29
Seroresponse was defined as ≥4 × LLOQ if baseline was \
Baseline to Day 29
Part B: GMT of Serum RSV-A and RSV-B NAbs at Day 181
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Day 181
Part B: GMFR of Serum RSV-A and RSV-B NAbs at Day 181
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Day 181
Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 181
95% CI for GM value was calculated based on the t-distribution of the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. SARS-CoV-2 variants included Wuhan-Hu-1 and B.1.1.529. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for Wuhan-Hu-1. LLOQ was 8 AU/mL and ULOQ was 24503 for B1.1.529.
Day 181
Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 181
95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 181
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs From Baseline to Day 181
Seroresponse was defined as ≥4 × LLOQ if baseline was \
Baseline to Day 181
Part B: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 181
Seroresponse was defined as ≥4 × LLOQ if baseline was \
Day 181
Part B: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 181
≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 * LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Baseline to Day 181
Part B: GMT of Serum RSV-A and RSV-B NAbs at Day 211
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Day 211
Part B: GMFR of Serum RSV-A and RSV-B NAbs at Day 211
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Day 211
Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 211
95% CI for GM value was calculated based on the t-distribution of the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. SARS-CoV-2 variants included Wuhan-Hu-1 and B.1.1.529. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for Wuhan-Hu-1. LLOQ was 8 AU/mL and ULOQ was 24503 for B1.1.529.
Day 211
Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 211
95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 211
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs at Day 211
Seroresponse was defined as ≥4 × LLOQ if baseline was \
Day 211
Part B: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 211
Seroresponse was defined as ≥4 × LLOQ if baseline was \
Day 211
Part B: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 211
≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 * LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
Day 211
Part C: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAbs From Baseline (Before Primary Vaccination) to Revaccination Day 29
Seroresponse was defined as ≥4 × LLOQ if baseline was \
Baseline (Before Primary Vaccination in Part B) to Revaccination Day 29
Part C: GMT of Serum RSV-A and RSV-B NAbs at Revaccination Day 361
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 IU/mL for RSV-B.
Revaccination Day 361
Part C: GMFR of Serum RSV-A and RSV-B NAbs at Revaccination Day 361
95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Revaccination Day 361
Part C: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAbs at Revaccination Day 361
Seroresponse was defined as ≥4 × LLOQ if baseline was \
Baseline to Revaccination Day 361
Part C: Percentage of Participants With ≥2-fold Increases From Baseline (Before Primary Vaccination) in RSV-A and RSV-B NAb Titers at Revaccination Day 361
≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 * LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 IU/mL for RSV-B.
Baseline to Revaccination Day 361
Up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C
Tucson
Arizona
85715
United States
Paragon Rx Clinical, Inc
Garden Grove
California
92703-1811
United States
Ark Clinical Research
Long Beach
California
90806
United States
Long Beach Clinical Trials, LLC (Site 1)
Long Beach
California
90806
United States
Long Beach Clinical Trials, LLC (Site 2)
Long Beach
California
90806
United States
Central Valley Research, LLC
Modesto
California
95350
United States
Velocity Clinical Research - Panorama City
Panorama City
California
91402-3022
United States
Empire Clinical Research
Pomona
California
91786
United States
Acclaim Clinical Research
San Diego
California
92120
United States
Medical Center For Clinical Research - M3 WR - ERN - PPDS
San Diego
California
92120
United States
Ark Clinical Research
Tustin
California
92780
United States
Chase Medical Research LLC
Waterbury
Connecticut
06708
United States
Teradan Clinical Trials
Brandon
Florida
33511-4925
United States
Revival Research Corporation - Clinedge - PPDS
Doral
Florida
33122
United States
Dolphin Medical Research
Doral
Florida
33172
United States
Indago Research and Health Center
Hialeah
Florida
33012
United States
Westside Center for Clinical Research - ERN - PPDS
Jacksonville
Florida
32205
United States
Suncoast Research Group LLC - ERN-PPDS
Miami
Florida
33135
United States
Suncoast Research Associates LLC - ERN - PPDS
Miami
Florida
33173
United States
Floridian Clinical Research - ClinEdge - PPDS
Miami Lakes
Florida
33016
United States
Tekton Research - Georgia - Platinum - PPDS
Chamblee
Georgia
30341
United States
Lifeline Primary Care / CCT Research
Lilburn
Georgia
30047-2832
United States
Georgia Clinic / CCT Research
Norcross
Georgia
30092-4544
United States
Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS
Savannah
Georgia
31406
United States
East-West Medical Research Institute
Honolulu
Hawaii
96814
United States
Meridian Clinical Research (Sioux City - Iowa)
Sioux City
Iowa
51106
United States
Meridian Clinical Research, LLC (Overland Park, Kansas) - Platinum - PPDS
Overland Park
Kansas
66210-1863
United States
Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS
Baton Rouge
Louisiana
70809
United States
Clinical Trials of SWLA, LLC
Lake Charles
Louisiana
70601
United States
Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS
Rockville
Maryland
20854-2957
United States
Clinical Research Institute, Inc - CRN - PPDS
Minneapolis
Minnesota
55402
United States
Meridian Clinical Research (Grand Island) - Platinum - PPDS
Grand Island
Nebraska
68803
United States
Meridian Clinical Research, LLC (Lincoln Nebraska) - Platinum - PPDS
Lincoln
Nebraska
68510
United States
Be Well Clinical Studies, LLC
Lincoln
Nebraska
68516
United States
Meridian Clinical Research
Norfolk
Nebraska
68701
United States
Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS
Omaha
Nebraska
68134
United States
Midwest Regional Health Services - CCT Research
Omaha
Nebraska
68144
United States
Clinical Research Center of Nevada - ERN - PPDS
Las Vegas
Nevada
89106
United States
Santa Rosa Medical Centers of Nevada - CCT Research
Las Vegas
Nevada
89119-5483
United States
Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
Endwell
New York
13760
United States
IMA Medical Research, PC.
New York
New York
10036-4103
United States
CHEAR Center LLC - ClinEdge - PPDS
The Bronx
New York
10455-3908
United States
Javara Research Inc. - Charlotte - Javara - PPDS
Charlotte
North Carolina
28210
United States
M3 Wake Research, Inc - M3 WR - ERN - PPDS
Raleigh
North Carolina
27612
United States
Velocity Clinical Research - Cleveland - ERN - PPDS
Cleveland
Ohio
44122
United States
Meridian Clinical Research - Cincinnati - Platinum - PPDS
Springdale
Ohio
45246
United States
Tekton Research
Moore
Oklahoma
73160-1386
United States
Velocity Clinical Research - Anderson - ERN - PPDS
Anderson
South Carolina
29621
United States
Velocity Clinical Research - Greenville - ERN - PPDS
Greenville
South Carolina
29615
United States
Trial Management Associates LLC - ERN - PPDS
Myrtle Beach
South Carolina
29572-4612
United States
Velocity Clinical Research - Spartanburg - ERN - PPDS
Spartanburg
South Carolina
29303-4225
United States
New Phase Research & Development
Knoxville
Tennessee
37909
United States
Benchmark Research - Austin - HyperCore - PPDS
Austin
Texas
78705
United States
Tekton Research - Beaumont - Platinum - PPDS
Beaumont
Texas
77706
United States
Zenos Clinical Research
Dallas
Texas
75230
United States
Milton Haber, M.D.
Laredo
Texas
78041
United States
Sun Research Institute
San Antonio
Texas
78215-1922
United States
Cope Family Medicine - Ogden Clinic
Bountiful
Utah
84010-4862
United States
CCT Research at Springville Dermatology
Springville
Utah
84663
United States
Javara Inc./Privia Medical Group INC
Forest
Virginia
24551
United States
Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS
Portsmouth
Virginia
23703
United States
Derived
Goswami J, Cardona JF, Hsu DC, Simorellis AK, Wilson L, Dhar R, Tomassini JE, Wang X, Kapoor A, Collins A, Righi V, Lan L, Du J, Zhou H, Stoszek SK, Shaw CA, Reuter C, Wilson E, Miller JM, Das R; study investigators. Safety and immunogenicity of mRNA-1345 RSV vaccine coadministered with an influenza or COVID-19 vaccine in adults aged 50 years or older: an observer-blinded, placebo-controlled, randomised, phase 3 trial. Lancet Infect Dis. 2025 Apr;25(4):411-423. doi: 10.1016/S1473-3099(24)00589-9. Epub 2024 Nov 25.
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
FG002
Part A: Afluria® Quadrivalent + Placebo
Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.
FG003
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
FG004
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
FG005
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
FG006
Part C: mRNA-1345 Revaccination
Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
FG000249 subjects
FG001690 subjects
FG002692 subjects
FG003560 subjects
FG004564 subjects
FG005562 subjects
FG0060 subjects
Received at Least 1 Dose of Any Study Injection
FG000249 subjects
FG001685 subjects5 randomized participants did not receive the study intervention
FG002689 subjects3 randomized participants did not receive the study intervention
FG003556 subjects4 randomized participants did not receive the study intervention
FG004562 subjects2 randomized participants did not receive the study intervention
FG005558 subjects4 randomized participants did not receive the study intervention
FG0060 subjects
Part B Day 1 Injection
Part B Day 1 Injection consisted of all randomized participants who received any study injection on Day 1.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003556 subjects
FG004562 subjects
FG005558 subjects
FG0060 subjects
Part B Day 29 Injection
Part B Day 29 Injection consisted of all randomized participants who received any study injection on Day 29.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003530 subjects
FG004535 subjects
FG005536 subjects
FG0060 subjects
Safety Set
Safety Set consisted of all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study intervention they actually received.
FG000249 subjects
FG001685 subjects
FG002689 subjects
FG003554 subjects
FG004562 subjects
FG005560 subjects
FG0060 subjects
Solicited Safety Set (Day 1 Injection)
Solicited Safety Set consisted of all randomized participants who received any study injection on Day 1 and contributed any solicited ARs.
FG000249 subjects
FG001678 subjects
FG002683 subjects
FG003553 subjects
FG004562 subjects
FG005557 subjects
FG0060 subjects
Part B Solicited Safety Set Day 29 Injection
Part B Solicited Safety Set Day 29 Injection consisted of all randomized participants who received any study injection on Day 29 and contributed any solicited ARs.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003522 subjects
FG004532 subjects
FG005528 subjects
FG0060 subjects
Per-protocol (PP) Set
PP Set consisted of all participants who received the assigned study injections according to protocol, complied with immunogenicity sampling, and had no major protocol deviations.
FG000232 subjects
FG001639 subjects
FG002626 subjects
FG003513 subjects
FG004514 subjects
FG005519 subjects
FG0060 subjects
COMPLETED
FG000233 subjects
FG001652 subjects
FG002643 subjects
FG003500 subjects
FG004516 subjects
FG005510 subjects
FG0060 subjects
NOT COMPLETED
FG00016 subjects
FG00138 subjects
FG00249 subjects
FG00360 subjects
FG00448 subjects
FG00552 subjects
FG0060 subjects
Type
Comment
Reasons
Lost to Follow-up
FG00012 subjects
FG00121 subjects
FG00238 subjects
FG00330 subjects
FG00425 subjects
FG00528 subjects
FG0060 subjects
Withdrawal by Subject
FG0004 subjects
FG00111 subjects
FG0028 subjects
FG00323 subjects
FG004
Protocol Violation
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0034 subjects
FG004
Death
FG0000 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG004
Other Than Specified
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Revaccination
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG006543 subjects
Part C Safety Set
Part C Safety Set consisted of all enrolled participants who received any revaccination of mRNA-1345.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part C Solicited Safety Set
Part C Solicited Safety Set consisted of all enrolled participants who received revaccination of mRNA-1345 and contributed any solicited ARs.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part C PP Set
Part C PP Set consisted of all enrolled participants who received planned revaccination of mRNA-1345, had prevaccination and at least 1 revaccination Day 29 assessment of immunogenicity, complied with immunogenicity sampling, and had no major protocol deviations.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Randomized Set included all participants who were randomized in the study, regardless of the participant's treatment status in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
BG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
BG002
Part A: Afluria® Quadrivalent + Placebo
Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.
BG003
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
BG004
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
BG005
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000249
BG001690
BG002692
BG003560
BG004564
BG005562
BG0063317
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
years
Title
Denominators
Categories
≥50 years of age
Title
Measurements
BG000249
BG001690
BG002692
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000141
BG001367
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00091
BG001240
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
White
BG000189
BG001524
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Part A: GMT of Serum RSV-B NAbs at Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and have no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Day 29
ID
Title
Description
OG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
OG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
Units
Counts
Participants
OG000232
OG001639
Title
Denominators
Categories
Title
Measurements
OG00010436.03(8973.29 to 12137.20)
OG0018909.80(8016.02 to 9903.24)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR
0.854
2-Sided
95
0.728
1.002
mRNA-1345+Afluria group compared mRNA-1345 alone group
Non-Inferiority
Lower bound of the 95% CI of GMR >0.667, using a noninferiority margin of 1.5.
Secondary
Part A: Percentage of Participants With Seroresponse in RSV-B NAbs at Day 29
Seroresponse was defined as ≥4 × LLOQ if baseline was \
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and have no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Number
95% Confidence Interval
percentage of participants
Day 29
ID
Title
Description
OG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
OG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
Units
Counts
Participants
Secondary
Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains at Day 181
Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Seroconversion was defined as a titer ≥1:40 if baseline was <1:10 or a 4-fold or greater rise from baseline in the titers if Baseline was ≥1:10. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and have no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Number
95% Confidence Interval
percentage of participants
Day 181
ID
Title
Description
OG000
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
OG001
Part A: Afluria® Quadrivalent + Placebo
Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.
Secondary
Part A: GMT of Serum RSV-A and RSV-B NAbs at Day 181
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and have no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Day 181
ID
Title
Description
OG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
OG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
Units
Counts
Secondary
Part A: Geometric Mean Fold Rise (GMFR) of Serum RSV-A and RSV-B NAbs at Day 181
95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 181
ID
Title
Description
OG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
OG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
Secondary
Part A: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 181
Seroresponse was defined as ≥4 × LLOQ if baseline was \
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Day 181
ID
Title
Description
OG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
OG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
Units
Counts
Secondary
Part A: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 181
≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 * LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Day 181
ID
Title
Description
OG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
OG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
Secondary
Part A: GMT of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181
Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 181
ID
Title
Description
OG000
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
OG001
Part A: Afluria® Quadrivalent + Placebo
Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.
Secondary
Part A: GMFR of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181
Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B. 95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 181
ID
Title
Description
OG000
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
OG001
Part A: Afluria® Quadrivalent + Placebo
Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.
Secondary
Part B: GMT of Serum RSV-B NAbs at Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Day 29
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: Percentage of Participants With Seroresponse in RSV-B NAbs From Baseline to Day 29
Seroresponse was defined as ≥4 × LLOQ if baseline was \
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Day 29
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: GMT of Serum RSV-A and RSV-B NAbs at Day 181
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Day 181
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: GMFR of Serum RSV-A and RSV-B NAbs at Day 181
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 181
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 181
95% CI for GM value was calculated based on the t-distribution of the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. SARS-CoV-2 variants included Wuhan-Hu-1 and B.1.1.529. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for Wuhan-Hu-1. LLOQ was 8 AU/mL and ULOQ was 24503 for B1.1.529.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Geometric Mean
95% Confidence Interval
AU/mL
Day 181
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 181
95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 181
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs From Baseline to Day 181
Seroresponse was defined as ≥4 × LLOQ if baseline was \
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Day 181
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 181
Seroresponse was defined as ≥4 × LLOQ if baseline was \
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Day 181
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 181
≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 * LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Day 181
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: GMT of Serum RSV-A and RSV-B NAbs at Day 211
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Day 211
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: GMFR of Serum RSV-A and RSV-B NAbs at Day 211
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 211
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 211
95% CI for GM value was calculated based on the t-distribution of the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. SARS-CoV-2 variants included Wuhan-Hu-1 and B.1.1.529. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for Wuhan-Hu-1. LLOQ was 8 AU/mL and ULOQ was 24503 for B1.1.529.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Geometric Mean
95% Confidence Interval
AU/mL
Day 211
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 211
95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 211
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs at Day 211
Seroresponse was defined as ≥4 × LLOQ if baseline was \
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Day 211
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 211
Seroresponse was defined as ≥4 × LLOQ if baseline was \
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Day 211
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part B: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 211
≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 * LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Day 211
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Secondary
Part C: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAbs From Baseline (Before Primary Vaccination) to Revaccination Day 29
Seroresponse was defined as ≥4 × LLOQ if baseline was \
PP Set: All participants received mRNA-1345 revaccination, had prerevaccination and at least 1 postinjection assessment of immunogenicity after revaccination, complied with immunogenicity testing schedule, and had no major protocol derivations. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Before Primary Vaccination in Part B) to Revaccination Day 29
ID
Title
Description
OG000
Part C: mRNA-1345 Primary Vaccination
Overall participants who received a single mRNA-1345 primary vaccination in Part B and enrolled in Part C.
OG001
Part C: mRNA-1345 Revaccincation
Participants received a single mRNA-1345 primary vaccination on Day 1 in Part B and then received revaccination with a single mRNA-1345 injection at least 12 months later (but not longer than 15 months) (Revaccination Day 1).
Secondary
Part C: GMT of Serum RSV-A and RSV-B NAbs at Revaccination Day 361
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 IU/mL for RSV-B.
PP Set: All participants who received mRNA-1345 revaccination, had prerevaccination and at least 1 postinjection assessment of immunogenicity after revaccination, complied with immunogenicity testing schedule, and had no major protocol derivations. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Revaccination Day 361
ID
Title
Description
OG000
Part C: mRNA-1345 Revaccincation
Participants received a single mRNA-1345 primary vaccination on Day 1 in Part B and then received revaccination with a single mRNA-1345 injection at least 12 months later (but not longer than 15 months) (Revaccination Day 1).
Units
Counts
Participants
OG000
Secondary
Part C: GMFR of Serum RSV-A and RSV-B NAbs at Revaccination Day 361
95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
PP Set: All participants received mRNA-1345 revaccination, had prerevaccination and at least 1 postinjection assessment of immunogenicity after revaccination, complied with immunogenicity testing schedule, and had no major protocol derivations. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
ratio
Revaccination Day 361
ID
Title
Description
OG000
Part C: mRNA-1345 Revaccincation
Participants received a single mRNA-1345 primary vaccination on Day 1 in Part B and then received revaccination with a single mRNA-1345 injection at least 12 months later (but not longer than 15 months) (Revaccination Day 1).
Units
Counts
Participants
OG000
Secondary
Part C: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAbs at Revaccination Day 361
Seroresponse was defined as ≥4 × LLOQ if baseline was \
PP Set: All participants received mRNA-1345 revaccination, had prerevaccination and at least 1 postinjection assessment of immunogenicity after revaccination, complied with immunogenicity testing schedule, and had no major protocol derivations. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Revaccination Day 361
ID
Title
Description
OG000
Part C: mRNA-1345 Revaccincation
Participants received a single mRNA-1345 primary vaccination on Day 1 in Part B and then received revaccination with a single mRNA-1345 injection at least 12 months later (but not longer than 15 months) (Revaccination Day 1).
Units
Counts
Participants
OG000
Secondary
Part C: Percentage of Participants With ≥2-fold Increases From Baseline (Before Primary Vaccination) in RSV-A and RSV-B NAb Titers at Revaccination Day 361
≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 * LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 IU/mL for RSV-B.
PP Set: All participants received mRNA-1345 revaccination, had prerevaccination and at least 1 postinjection assessment of immunogenicity after revaccination, complied with immunogenicity testing schedule, and had no major protocol derivations. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Revaccination Day 361
ID
Title
Description
OG000
Part C: mRNA-1345 Revaccincation
Participants received a single mRNA-1345 primary vaccination on Day 1 in Part B and then received revaccination with a single mRNA-1345 injection at least 12 months later (but not longer than 15 months) (Revaccination Day 1).
Units
Counts
Participants
Primary
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Solicited Safety Set included all randomized participants who received any study intervention and contributed any solicited ARs data from the time of study injection on Day 1 through the following 6 days. Participants were included in the treatment arm corresponding to the study drug they actually received.
Posted
Count of Participants
Participants
Within 7 days after Day 1 injection
ID
Title
Description
OG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
OG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
Primary
Part A: Number of Participants With Unsolicited Adverse Events (AEs) After Day 1 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. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.
Posted
Count of Participants
Participants
Day 1 through Day 28 (28 days after Day 1 injection)
ID
Title
Description
OG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
OG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
Primary
Part A: Number of Participants With Medically Attended AEs (MAAEs), SAEs, Adverse Events of Special Interest (AESIs), and AEs Leading to Withdrawal
A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. 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, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.
Posted
Count of Participants
Participants
Day 1 through Day 181 (end of Study Part A)
ID
Title
Description
OG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
OG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
Primary
Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) Neutralizing Antibodies (NAbs) at Day 29
Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 international units (IU)/milliliter (mL) and ULOQ was 259061 IU/mL for RSV-A. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Day 29
ID
Title
Description
OG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
OG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
Primary
Part A: Percentage of Participants With Seroresponse in RSV-A NAbs at Day 29
Seroresponse was defined as ≥4 × lower limit of quantification (LLOQ) if baseline was \
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Number
95% Confidence Interval
percentage of participants
Day 29
ID
Title
Description
OG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
OG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
Units
Counts
Participants
Primary
Part A: GMT of Serum Anti-hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29
Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 29
ID
Title
Description
OG000
Part A: mRNA-1345 + Afluria® Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
OG001
Part A: Afluria® Quadrivalent + Placebo
Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.
Primary
Part B: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 1 Injection
Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Solicited Safety Set included all randomized participants who received any study intervention and contributed any solicited ARs data from the time of study injection on Day 1 through the following 6 days. Participants were included in the treatment arm corresponding to the study drug they actually received. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Count of Participants
Participants
Within 7 days after Day 1 injection
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Primary
Part B: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 29 Injection
Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Part B Solicited Safety Set Day 29 Injection consisted of all randomized participants who received any study injection on Day 29 and contributed any solicited ARs. Participants were included in the treatment arm corresponding to the study drug they actually received. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Count of Participants
Participants
Within 7 days after Day 29 injection
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Primary
Part B: Number of Participants With Unsolicited AEs After Day 1 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 PT/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. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Safety Set Day 1 injection included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.
Posted
Count of Participants
Participants
Day 1 through Day 28 (28 days after Day 1 injection)
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Primary
Part B: Number of Participants With Unsolicited AEs After Day 29 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. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Safety Set Day 29 injection included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.
Posted
Count of Participants
Participants
Day 29 through Day 57 (28 days after Day 29 injection)
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Primary
Part B: Number of Participants With MAAEs, SAEs, AESIs, and AEs Leading to Withdrawal
A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. 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, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.
Posted
Count of Participants
Participants
Day 1 through Day 211
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Primary
Part B: GMT of Serum RSV-A at Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Day 29
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Primary
Part B: Percentage of Participants With Seroresponse for RSV-A Neutralizing Abs From Baseline to Day 29
Seroresponse was defined as ≥4 × LLOQ if baseline was \
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Day 29
ID
Title
Description
OG000
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG001
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Primary
Part B: Geometric Mean Concentration (GMC) of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 29
The model-based GM titer was estimated on ANCOVA model. SARS-CoV-2 variants included Wuhan-Hu-1 and B.1.1.529. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 arbitrary units (AU)/milliliters (mL) and ULOQ was 111433 AU/mL for Wuhan-Hu-1. LLOQ was 8 and ULOQ was B.1.1.529 for B1.1.529. As prespecified, only arms where participants received mRNA-1273.214 are presented for this outcome measure.
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
AU/mL
Day 29
ID
Title
Description
OG000
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
OG001
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Primary
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs From Baseline to Day 29
Seroresponse was defined as ≥4 × LLOQ if baseline was \
PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Day 29
ID
Title
Description
OG000
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
OG001
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Primary
Part C: Number of Participants With Solicited Local and Systemic Within 7 Days After Revaccination Day 1
Solicited ARs were collected in an electronic eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Solicited Safety Set included all participants who received revaccination with mRNA-1345 and contributed any solicited AR data. Participants were included in the treatment arm corresponding to the study drug they actually received.
Posted
Count of Participants
Participants
Within 7 days after Day 1 revaccination
ID
Title
Description
OG000
Part C: mRNA-1345 Revaccincation
Overall participants who received a single mRNA-1345 primary vaccination on Day 1 in Part B and then received revaccination with a single mRNA-1345 injection at least 12 months later (but not longer than 15 months) (Revaccination Day 1).
Units
Counts
Participants
Primary
Part C: Number of Participants With Unsolicited AEs Within 28 Days After Revaccination Day 1
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 PT/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. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Safety Set included all participants who received any revaccination with mRNA-1345. Participants were included in the treatment arm corresponding to the study drug they actually received.
Posted
Count of Participants
Participants
Revaccination Day 1 through Day 28 (28 days after revaccination Day 1)
ID
Title
Description
OG000
Part C: mRNA-1345 Revaccincation
Overall participants who received a single mRNA-1345 primary vaccination on Day 1 in Part B and then received revaccination with a single mRNA-1345 injection at least 12 months later (but not longer than 15 months) (Revaccination Day 1).
Units
Counts
Participants
Primary
Part C: Number of Participants With MAAEs
A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner.
Safety Set included all participants who received any revaccination with mRNA-1345. Participants were included in the treatment arm corresponding to the study drug they actually received.
Posted
Count of Participants
Participants
Revaccination Day 1 through Day 181
ID
Title
Description
OG000
Part C: mRNA-1345 Revaccincation
Overall participants who received a single mRNA-1345 primary vaccination on Day 1 in Part B and then received revaccination with a single mRNA-1345 injection at least 12 months later (but not longer than 15 months) (Revaccination Day 1).
Units
Counts
Participants
OG000
Primary
Part C: Number of Participants With SAEs, AESIs, and AEs Leading to Withdrawal
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, was a congenital anomaly/birth defect, or was an important medical event. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Safety Set included all participants who received any revaccination with mRNA-1345. Participants were included in the treatment arm corresponding to the study drug they actually received.
Posted
Count of Participants
Participants
Revaccination Day 1 through Day 361
ID
Title
Description
OG000
Part C: mRNA-1345 Revaccincation
Overall participants who received a single mRNA-1345 primary vaccination on Day 1 in Part B and then received revaccination with a single mRNA-1345 injection at least 12 months later (but not longer than 15 months) (Revaccination Day 1).
Units
Counts
Participants
Primary
Part C: GMT of Serum RSV-A and RSV-B NAbs mRNA-1345 Revaccination Day 29 Compared to Primary Vaccination Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 IU/mL for RSV-B.
mRNA-1345 Revaccination Day 29 and mRNA-1345 primary vaccination Day 29 (received in Part B) are presented.
PP Set: participants received mRNA-1345 revaccination, had prerevaccination and at least 1 postinjection assessment of immunogenicity after revaccination, complied with immunogenicity testing schedule, and had no major protocol derivations. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Primary Vaccination Day 29 to Revaccination Day 29
ID
Title
Description
OG000
Part C: mRNA-1345 Primary Vaccination
Overall participants who received a single mRNA-1345 primary vaccination in Part B and enrolled in Part C.
OG001
Part C: mRNA-1345 Revaccincation
Participants received a single mRNA-1345 primary vaccination on Day 1 in Part B and then received revaccination with a single mRNA-1345 injection at least 12 months later (but not longer than 15 months) (Revaccination Day 1).
Other Pre-specified
Number of Deaths During the Study
A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable and/or the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.
Randomized Set included all participants who were randomized in the study, regardless of the participant's treatment status in the study.
Posted
Count of Participants
Participants
Up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C
ID
Title
Description
OG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
OG001
Part A: mRNA-1345 + Afluria® Quadrivalent
Time Frame
All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation.
Description
The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: mRNA-1345 + Placebo
Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.
0
249
4
249
0
249
EG001
Part A: mRNA-1345 + Afluria Quadrivalent
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
3
690
28
685
0
685
EG002
Part A: Afluria Quadrivalent + Placebo
Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.
1
692
24
689
0
689
EG003
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
1
560
18
554
0
554
EG004
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
0
564
13
562
0
562
EG005
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
0
562
10
560
0
560
EG006
Part C: Revaccination
Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
3
543
28
543
0
543
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abscess neck
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG0030 events0 affected554 at risk
EG0040 events0 affected562 at risk
EG0050 events0 affected560 at risk
EG0060 events0 affected543 at risk
Bacterial sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0012 events2 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Cellulitis staphylococcal
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Metapneumovirus bronchiolitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Pneumonia necrotising
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0013 events3 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Septic shock
Infections and infestations
MedDRA 25.0
Systematic Assessment
A participant in the Part C: Revaccination group experienced a fatal SAE of septic shock considered unrelated to study drug by the investigator.
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Upper respiratory tract infection bacterial
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Brain neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Breast cancer female
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
A participant in the Part A: mRNA-1345 + Afluria Quadrivalent group experienced a fatal SAE of gastric cancer considered unrelated to study drug by the investigator.
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Hepatic cancer stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Laryngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Lung carcinoma cell type unspecified stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Neuroendocrine tumour of the rectum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Parathyroid tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Pituitary tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Triple negative breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
A participant in the Part C: Revaccination group experienced a fatal SAE of diabetic ketoacidosis considered unrelated to study drug by the investigator.
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Acute psychosis
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Delirium tremens
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Intentional self-injury
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0012 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Subdural effusion
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Syncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0022 events2 affected689 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Acute left ventricular failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Aortic valve stenosis
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 25.0
Systematic Assessment
A participant in the Part C: Revaccination group experienced a fatal SAE of cardiac arrest considered unrelated to study drug by the investigator.
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
A participant in the Part A: Afluria Quadrivalent + Placebo group experienced a fatal SAE of cardiac failure considered unrelated to study drug by the investigator.
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Hypertensive urgency
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0022 events2 affected689 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Venous occlusion
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0022 events2 affected689 at risk
EG003
Abdominal adhesions
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Abdominal incarcerated hernia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Large intestinal stenosis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Mallory-Weiss syndrome
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Necrotising oesophagitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Portal hypertension
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Death
General disorders
MedDRA 25.0
Systematic Assessment
A participant in the Part A: mRNA-1345 + Afluria Quadrivalent group and a participant in the Part B: mRNA-1345 + Placebo + mRNA-1273.214 group had SAEs of death considered unrelated to study drug by the investigator.
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Comminuted fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0021 events1 affected689 at risk
EG003
Limb traumatic amputation
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0010 events0 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected249 at risk
EG0011 events1 affected685 at risk
EG0020 events0 affected689 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
A participant in the Part A: mRNA-1345 + Afluria Quadrivalent group experienced a fatal SAE of subdural hematoma (secondary to a fall) considered unrelated to study drug by the investigator.
mRNA-1345+Afluria group compared mRNA-1345 alone group
Non-Inferiority
Lower bound of the 95% CI of the SRR difference >-10%, using noninferiority margin of 10%.
Units
Counts
Participants
OG000609
OG001595
Title
Denominators
Categories
Influenza A H1N1 Antibody
Title
Measurements
OG00041.1(37.1 to 45.1)
OG00138.8(34.9 to 42.9)
Influenza A H3N2 Antibody
Title
Measurements
OG00029.4(25.8 to 33.2)
OG00128.7(25.1 to 32.6)
Influenza B Washington Antibody
Title
Measurements
OG00019.5(16.5 to 22.9)
OG00119.7(16.5 to 23.1)
Influenza B Phuket Antibody
Title
Measurements
OG00017.2(14.3 to 20.5)
OG00118.8(15.8 to 22.2)
Participants
OG000218
OG001613
Title
Denominators
Categories
RSV-A
ParticipantsOG000218
ParticipantsOG001612
Title
Measurements
OG0007551.13(6504.13 to 8766.68)
OG0016429.48(5850.16 to 7066.17)
RSV-B
ParticipantsOG000218
ParticipantsOG001613
Title
Measurements
OG0002402.86(2120.18 to 2723.23)
OG001
Units
Counts
Participants
OG000218
OG001613
Title
Denominators
Categories
RSV-A
ParticipantsOG000218
ParticipantsOG001612
Title
Measurements
OG0003.46(2.97 to 4.04)
OG0012.19(1.99 to 2.40)
RSV-B
ParticipantsOG000218
ParticipantsOG001613
Title
Measurements
OG0001.32(1.17 to 1.49)
OG001
Participants
OG000218
OG001613
Title
Denominators
Categories
RSV-A
ParticipantsOG000218
ParticipantsOG001612
Title
Measurements
OG00046.8(40.0 to 53.6)
OG00129.9(26.3 to 33.7)
RSV-B
ParticipantsOG000218
ParticipantsOG001613
Title
Measurements
OG00013.3(9.1 to 18.5)
OG001
Units
Counts
Participants
OG000218
OG001613
Title
Denominators
Categories
RSV-A
ParticipantsOG000218
ParticipantsOG001612
Title
Measurements
OG00067.0(60.3 to 73.2)
OG00154.1(50.0 to 58.1)
RSV-B
ParticipantsOG000218
ParticipantsOG001613
Title
Measurements
OG00032.1(26.0 to 38.7)
OG001
Units
Counts
Participants
OG000613
OG001601
Title
Denominators
Categories
Influenza A H1N1 Antibody
Title
Measurements
OG000155.59(138.10 to 175.31)
OG001156.47(139.65 to 175.33)
Influenza A H3N2 Antibody
Title
Measurements
OG000113.58(101.54 to 127.06)
OG001109.36(98.28 to 121.68)
Influenza B Washington Antibody
Title
Measurements
OG00032.11(29.10 to 35.43)
OG00135.03(31.76 to 38.64)
Influenza B Phuket Antibody
Title
Measurements
OG00025.64(23.34 to 28.17)
OG00126.43(24.17 to 28.91)
Units
Counts
Participants
OG000609
OG001595
Title
Denominators
Categories
Influenza A H1N1 Antibody
Title
Measurements
OG0003.21(2.80 to 3.68)
OG0013.08(2.70 to 3.51)
Influenza A H3N2 Antibody
Title
Measurements
OG0002.28(2.04 to 2.55)
OG0012.23(2.00 to 2.49)
Influenza B Washington Antibody
Title
Measurements
OG0001.80(1.66 to 1.96)
OG0011.95(1.79 to 2.13)
Influenza B Phuket Antibody
Title
Measurements
OG0001.76(1.63 to 1.90)
OG0011.79(1.66 to 1.93)
Units
Counts
Participants
OG000511
OG001513
Title
Denominators
Categories
Title
Measurements
OG0006584.54(5961.73 to 7272.40)
OG0015843.94(5292.14 to 6453.28)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR
0.888
2-Sided
95
0.791
0.995
mRNA-1345+mRNA-1273.214 compared with mRNA-1345 alone
Non-Inferiority
Lower bound of the 95% CI of GMR >0.667, using a noninferiority margin of 1.5.
Units
Counts
Participants
OG000511
OG001513
Title
Denominators
Categories
Title
Measurements
OG00051.9(47.4 to 56.3)
OG00146.0(41.6 to 50.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference
-5.9
2-Sided
95
-11.9
0.3
mRNA-1345+mRNA-1273.214 compared with mRNA-1345 alone
Non-Inferiority
Lower bound of the 95% CI of the SRR difference >-10%, using noninferiority margin of 10%.
Units
Counts
Participants
OG000476
OG001487
Title
Denominators
Categories
RSV-A
Title
Measurements
OG0006456.32(5830.84 to 7148.91)
OG0015221.87(4723.14 to 5773.26)
RSV-B
Title
Measurements
OG0002447.67(2236.91 to 2678.28)
OG0012274.83(2070.95 to 2498.79)
Units
Counts
Participants
OG000476
OG001487
Title
Denominators
Categories
RSV-A
ParticipantsOG000476
ParticipantsOG001487
Title
Measurements
OG0002.91(2.65 to 3.20)
OG0012.58(2.36 to 2.82)
RSV-B
ParticipantsOG000475
ParticipantsOG001487
Title
Measurements
OG0001.61(1.48 to 1.75)
OG001
OG002
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Units
Counts
Participants
OG000476
OG001485
OG002486
Title
Denominators
Categories
Wuhan-Hu-1
Title
Measurements
OG0004075.34(3722.53 to 4461.58)
OG0013615.45(3272.04 to 3994.91)
OG0023665.39(3335.37 to 4028.07)
B.1.1.529
Title
Measurements
OG0001002.35(894.17 to 1123.61)
OG001889.75(791.84 to 999.76)
OG002919.49(820.46 to 1030.46)
OG002
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Units
Counts
Participants
OG000476
OG001485
OG002486
Title
Denominators
Categories
Wuhan-Hu-1
ParticipantsOG000474
ParticipantsOG001479
ParticipantsOG002484
Title
Measurements
OG0002.12(1.90 to 2.38)
OG0011.94(1.72 to 2.19)
OG0021.84(1.65 to 2.06)
B.1.1.529
ParticipantsOG000476
ParticipantsOG001485
ParticipantsOG002486
Title
Measurements
OG000
OG002
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Units
Counts
Participants
OG000476
OG001485
OG002486
Title
Denominators
Categories
Wuhan-Hu-1
ParticipantsOG000474
ParticipantsOG001479
ParticipantsOG002484
Title
Measurements
OG00024.1(20.3 to 28.2)
OG00123.6(19.9 to 27.7)
OG00219.8(16.4 to 23.7)
B.1.1.529
ParticipantsOG000476
ParticipantsOG001485
ParticipantsOG002486
Title
Measurements
OG000
Units
Counts
Participants
OG000476
OG001487
Title
Denominators
Categories
RSV-A
ParticipantsOG000476
ParticipantsOG001486
Title
Measurements
OG00034.9(30.6 to 39.3)
OG00130.2(26.1 to 34.5)
RSV-B
ParticipantsOG000475
ParticipantsOG001487
Title
Measurements
OG00014.9(11.9 to 18.5)
OG001
Units
Counts
Participants
OG000476
OG001487
Title
Denominators
Categories
RSV-A
ParticipantsOG000476
ParticipantsOG001487
Title
Measurements
OG00062.8(58.3 to 67.2)
OG00158.3(53.8 to 62.7)
RSV-B
ParticipantsOG000475
ParticipantsOG001487
Title
Measurements
OG00036.4(32.1 to 40.9)
OG001
Units
Counts
Participants
OG000474
OG001487
Title
Denominators
Categories
RSV-A
ParticipantsOG000474
ParticipantsOG001487
Title
Measurements
OG0005921.09(5357.33 to 6544.17)
OG0014696.74(4245.92 to 5195.44)
RSV-B
ParticipantsOG000473
ParticipantsOG001487
Title
Measurements
OG0002261.26(2069.70 to 2470.56)
OG001
Units
Counts
Participants
OG000474
OG001487
Title
Denominators
Categories
RSV-A
ParticipantsOG000474
ParticipantsOG001486
Title
Measurements
OG0002.71(2.48 to 2.98)
OG0012.35(2.15 to 2.56)
RSV-B
ParticipantsOG000472
ParticipantsOG001487
Title
Measurements
OG0001.50(1.39 to 1.63)
OG001
OG002
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Units
Counts
Participants
OG000471
OG001485
OG002486
Title
Denominators
Categories
Wuhan-Hu-1
Title
Measurements
OG0003551.74(3245.10 to 3887.35)
OG0013034.11(2743.48 to 3355.54)
OG0023123.69(2841.55 to 3433.84)
B.1.1.529
Title
Measurements
OG000923.10(826.89 to 1030.51)
OG001797.17(708.18 to 897.33)
OG002795.90(709.19 to 893.21)
OG002
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Units
Counts
Participants
OG000471
OG001485
OG002486
Title
Denominators
Categories
Wuhan-Hu-1
ParticipantsOG000469
ParticipantsOG001479
ParticipantsOG002484
Title
Measurements
OG0001.87(1.66 to 2.09)
OG0011.64(1.45 to 1.85)
OG0021.59(1.42 to 1.77)
B.1.1.529
ParticipantsOG000471
ParticipantsOG001485
ParticipantsOG002486
Title
Measurements
OG000
OG002
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Units
Counts
Participants
OG000471
OG001485
OG002486
Title
Denominators
Categories
Wuhan-Hu-1
ParticipantsOG000469
ParticipantsOG001479
ParticipantsOG002484
Title
Measurements
OG00021.1(17.5 to 25.1)
OG00120.3(16.7 to 24.1)
OG00217.8(14.5 to 21.5)
B.1.1.529
ParticipantsOG000471
ParticipantsOG001485
ParticipantsOG002486
Title
Measurements
OG000
Units
Counts
Participants
OG000474
OG001487
Title
Denominators
Categories
RSV-A
ParticipantsOG000474
ParticipantsOG001486
Title
Measurements
OG00032.5(28.3 to 36.9)
OG00126.5(22.7 to 30.7)
RSV-B
ParticipantsOG000472
ParticipantsOG001487
Title
Measurements
OG00012.3(9.5 to 15.6)
OG001
Units
Counts
Participants
OG000474
OG001487
Title
Denominators
Categories
RSV-A
ParticipantsOG000474
ParticipantsOG001486
Title
Measurements
OG00057.8(53.2 to 62.3)
OG00153.7(49.2 to 58.2)
RSV-B
ParticipantsOG000472
ParticipantsOG001487
Title
Measurements
OG00033.7(29.4 to 38.1)
OG001
Units
Counts
Participants
OG000523
OG001524
Title
Denominators
Categories
RSV-A
ParticipantsOG000518
ParticipantsOG001524
Title
Measurements
OG00075.3(71.3 to 78.9)
OG00177.5(73.7 to 81.0)
RSV-B
ParticipantsOG000523
ParticipantsOG001524
Title
Measurements
OG00048.2(43.8 to 52.6)
OG001
497
Title
Denominators
Categories
RSV-A
ParticipantsOG000493
Title
Measurements
OG0004708.27(4279.78 to 5179.67)
RSV-B
ParticipantsOG000497
Title
Measurements
OG0002251.24(2054.09 to 2467.32)
496
Title
Denominators
Categories
RSV-A
ParticipantsOG000492
Title
Measurements
OG0002.26(2.06 to 2.48)
RSV-B
ParticipantsOG000496
Title
Measurements
OG0001.42(1.31 to 1.53)
496
Title
Denominators
Categories
RSV-A
ParticipantsOG000492
Title
Measurements
OG00025.8(22.0 to 29.9)
RSV-B
ParticipantsOG000496
Title
Measurements
OG00011.5(8.8 to 14.6)
OG000496
Title
Denominators
Categories
RSV-A
ParticipantsOG000492
Title
Measurements
OG00053.0(48.5 to 57.5)
RSV-B
ParticipantsOG000496
Title
Measurements
OG00032.7(28.5 to 37.0)
OG002
Part A: Afluria® Quadrivalent + Placebo
Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.
Units
Counts
Participants
OG000249
OG001678
OG002683
Title
Denominators
Categories
Title
Measurements
OG000147
OG001395
OG002291
OG002
Part A: Afluria® Quadrivalent + Placebo
Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.
Units
Counts
Participants
OG000249
OG001685
OG002689
Title
Denominators
Categories
Title
Measurements
OG00021
OG00157
OG00246
OG002
Part A: Afluria® Quadrivalent + Placebo
Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.
Units
Counts
Participants
OG000249
OG001685
OG002689
Title
Denominators
Categories
MAAE
Title
Measurements
OG00041
OG001136
OG002114
SAE
Title
Measurements
OG0004
OG00128
OG00224
AESI
Title
Measurements
OG0000
OG0011
OG0021
AEs Leading to Withdrawal
Title
Measurements
OG0000
OG0013
OG0021
Units
Counts
Participants
OG000232
OG001639
Title
Denominators
Categories
Title
Measurements
OG00017271.72(14448.78 to 20646.20)
OG00113929.98(12291.04 to 15787.47)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR
0.807
2-Sided
95
0.668
0.974
mRNA-1345+Afluria group compared mRNA-1345 alone group
Non-Inferiority
Lower bound of the 95% CI of geometric mean ratio (GMR) >0.667, using a noninferiority margin of 1.5.
OG000232
OG001639
Title
Denominators
Categories
Title
Measurements
OG00072.4(66.2 to 78.1)
OG00161.2(57.3 to 65.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference
-11.2
2-Sided
95
-17.9
-4.1
mRNA-1345+Afluria group compared mRNA-1345 alone group
Non-Inferiority
Lower bound of the 95% CI of the SRR difference >-10%, using noninferiority margin of 10%.
Units
Counts
Participants
OG000630
OG001619
Title
Denominators
Categories
Influenza A H1N1 Antibody
Title
Measurements
OG000271.27(239.71 to 306.99)
OG001303.92(268.24 to 344.35)
Influenza A H3N2 Antibody
Title
Measurements
OG000144.14(130.37 to 159.36)
OG001148.69(134.35 to 164.55)
Influenza B Washington Antibody
Title
Measurements
OG00057.59(52.01 to 63.77)
OG00162.13(56.05 to 68.86)
Influenza B Phuket Antibody
Title
Measurements
OG00038.52(34.91 to 42.50)
OG00142.40(38.39 to 46.82)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Influenza A H1N1 Antibody
GMR
0.893
2-Sided
95
0.772
1.032
mRNA-1345+Afluria group at Day 29 compared with the GMT of anti-HA Ab in the Afluria alone group
Non-Inferiority
Lower bound of the 95% CI of GMR >0.667, using a noninferiority margin of 1.5.
OG000
OG001
Influenza A H3N2 Antibody
GMR
0.969
2-Sided
95
0.861
1.091
mRNA-1345+Afluria group at Day 29 compared with the GMT of anti-HA Ab in the Afluria alone group
Non-Inferiority
Lower bound of the 95% CI of geometric mean ratio (GMR) >0.667, using a noninferiority margin of 1.5.
OG000
OG001
Influenza B Washington Antibody
GMR
0.927
2-Sided
95
0.822
1.045
mRNA-1345+Afluria group at Day 29 compared with the GMT of anti-HA Ab in the Afluria alone group
Non-Inferiority
Lower bound of the 95% CI of geometric mean ratio (GMR) >0.667, using a noninferiority margin of 1.5.
OG000
OG001
Influenza B Phuket Antibody
GMR
0.909
2-Sided
95
0.809
1.020
mRNA-1345+Afluria group at Day 29 compared with the GMT of anti-HA Ab in the Afluria alone group
Non-Inferiority
Lower bound of the 95% CI of geometric mean ratio (GMR) >0.667, using a noninferiority margin of 1.5.
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
OG002
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Units
Counts
Participants
OG000553
OG001557
OG002556
Title
Denominators
Categories
Title
Measurements
OG000358
OG001394
OG002361
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
OG002
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Units
Counts
Participants
OG000522
OG001532
OG002528
Title
Denominators
Categories
Title
Measurements
OG000265
OG001147
OG002148
OG002
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Units
Counts
Participants
OG000554
OG001562
OG002560
Title
Denominators
Categories
Title
Measurements
OG00041
OG00154
OG00244
OG002
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Units
Counts
Participants
OG000530
OG001535
OG002536
Title
Denominators
Categories
Title
Measurements
OG00031
OG00125
OG00226
OG002
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
Units
Counts
Participants
OG000554
OG001562
OG002560
Title
Denominators
Categories
MAAEs
Title
Measurements
OG000109
OG001107
OG00297
SAEs
Title
Measurements
OG00018
OG00113
OG00210
AESIs
Title
Measurements
OG0005
OG0012
OG0027
AEs Leading to Withdrawal
Title
Measurements
OG0001
OG0010
OG0020
Units
Counts
Participants
OG000508
OG001506
Title
Denominators
Categories
Title
Measurements
OG00019071.03(17130.14 to 21231.84)
OG00115171.23(13626.94 to 16890.53)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR
0.796
2-Sided
95
0.702
0.901
mRNA-1345+mRNA-1273.214 compared to mRNA-1345 alone
Non-Inferiority
Lower bound of the 95% CI of ratio of the GMT (GMR) >0.667, using a noninferiority margin of 1.5.
Units
Counts
Participants
OG000508
OG001506
Title
Denominators
Categories
Title
Measurements
OG00075.4(71.4 to 79.1)
OG00170.9(66.8 to 74.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference
-4.4
2-Sided
95
-9.9
1.0
mRNA-1345+mRNA-1273.214 compared to mRNA-1345 alone
Non-Inferiority
Lower bound of the 95% CI of the SRR difference >-10%, using noninferiority margin of 10%.
Units
Counts
Participants
OG000513
OG001519
Title
Denominators
Categories
Wuhan-Hu-1
ParticipantsOG000501
ParticipantsOG001512
Title
Measurements
OG0009881.69(9097.35 to 10733.66)
OG00110300.49(9490.13 to 11180.04)
B.1.1.529
ParticipantsOG000513
ParticipantsOG001519
Title
Measurements
OG0002353.15(2115.26 to 2617.80)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR for Wuhan-Hu-1
GMR
0.959
2-Sided
95
0.872
1.056
mRNA-1345+mRNA-1273.214 compared to mRNA-1273.214 alone
Non-Inferiority
Lower bound of the 95% CI of ratio of the GMT (GMR) >0.667, using a noninferiority margin of 1.5.
OG000
OG001
GMR for B.1.1.529
GMR
1.004
2-Sided
95
0.888
1.137
mRNA-1345+mRNA-1273.214 compared to mRNA-1273.214 alone
Non-Inferiority
Lower bound of the 95% CI of ratio of the GMT (GMR) >0.667, using a noninferiority margin of 1.5.
Units
Counts
Participants
OG000513
OG001519
Title
Denominators
Categories
Wuhan-Hu-1
ParticipantsOG000501
ParticipantsOG001512
Title
Measurements
OG00052.7(48.2 to 57.1)
OG00152.5(48.1 to 56.9)
B.1.1.529
ParticipantsOG000513
ParticipantsOG001519
Title
Measurements
OG00068.4(64.2 to 72.4)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
SRR difference for Wuhan-Hu-1
Difference
0.2
2-Sided
95
-6.0
6.3
mRNA-1345+mRNA-1273.214 compared to mRNA-1273.214 alone
Non-Inferiority
Lower bound of the 95% CI of the SRR difference >-10%, using noninferiority margin of 10%.
OG000
OG001
SRR difference for B.1.1.529
Difference
-0.9
2-Sided
95
-6.6
4.7
mRNA-1345+mRNA-1273.214 compared to mRNA-1273.214 alone
Non-Inferiority
Lower bound of the 95% CI of the SRR difference >-10%, using noninferiority margin of 10%.
OG000543
Title
Denominators
Categories
Title
Measurements
OG000338
OG000543
Title
Denominators
Categories
Title
Measurements
OG00031
543
Title
Denominators
Categories
Title
Measurements
OG000105
OG000543
Title
Denominators
Categories
SAEs
Title
Measurements
OG00028
AESIs
Title
Measurements
OG0002
AEs Leading to Withdrawal
Title
Measurements
OG0005
Units
Counts
Participants
OG000524
OG001525
Title
Denominators
Categories
RSV-A
ParticipantsOG000519
ParticipantsOG001525
Title
Measurements
OG00018190.30(16467.13 to 20093.79)
OG00119649.18(18017.92 to 21428.12)
RSV-B
ParticipantsOG000524
ParticipantsOG001525
Title
Measurements
OG0006746.41(6136.32 to 7417.16)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR of RSV-A. GMR was calculated by back transforming the mean of paired difference of antibody levels on the logarithmic scale between revaccination Day 29 and primary vaccination Day 29.
GMR
1.077
2-Sided
95
0.995
1.166
The 95% CI for the GMR is based on t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Non-Inferiority
Lower bound of the 95% CI of ratio of the GMT (GMR) >0.667, using a noninferiority margin of 1.5.
OG000
OG001
GMR of RSV-B. GMR was calculated by back transforming the mean of paired difference of antibody levels on the logarithmic scale between revaccination Day 29 and primary vaccination Day 29.
GMR
0.909
2-Sided
95
0.839
0.984
The 95% CI for the GMR is based on t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Non-Inferiority
Lower bound of the 95% CI of ratio of the GMT (GMR) >0.667, using a noninferiority margin of 1.5.
Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.
OG002
Part A: Afluria® Quadrivalent + Placebo
Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.
OG003
Part B: mRNA-1345 + Placebo + mRNA-1273.214
Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1.
(Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)
OG004
Part B: mRNA-1345 + mRNA-1273.214 + Placebo
Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
OG005
Part B: mRNA-1273.214 + Placebo + Placebo
Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1.
(Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)
OG006
Part C: mRNA-1345 Revaccination
Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.