| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07117487 | A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in Adult Participants ≥60 Years of Age | PHASE3 | COMPLETED | 507 | — | — | Aug 5, 2025 | Mar 27, 2026 | May 4, 2026 | 11 | United States |
| NCT06067230 | A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults | PHASE3 | ACTIVE NOT_RECRUITING | 1,153 | — | — | Oct 6, 2023 | Jul 30, 2026 | Aug 8, 2025 | 44 | United States, Canada +2 |
| NCT06060457 | A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age | PHASE3 | COMPLETED | 1,900 | — | — | Sep 25, 2023 | Jun 7, 2024 | Jul 30, 2025 | 34 | United States |
| NCT05330975 | A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age | PHASE3 | COMPLETED | 3,317 | — | — | Apr 1, 2022 | Nov 8, 2024 | Dec 30, 2025 | 62 | United States |
| NCT06143046 | A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers | PHASE2 | ACTIVE NOT_RECRUITING | 360 | — | — | Nov 15, 2023 | May 27, 2026 | Feb 5, 2026 | 56 | United States, Canada +6 |
| NCT06097299 | A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus | PHASE2 | COMPLETED | 346 | — | — | Oct 24, 2023 | Jun 27, 2025 | Jul 10, 2025 | 50 | United States, Panama |
| NCT05127434 | A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age | PHASE2 | COMPLETED | 36,814 | — | — | Nov 17, 2021 | Jul 28, 2025 | Aug 19, 2025 | 269 | United States, Argentina +21 |
| NCT05743881 | A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months | PHASE1 | ACTIVE NOT_RECRUITING | 186 | — | — | Feb 15, 2023 | Sep 30, 2026 | Nov 24, 2025 | 50 | United States, Australia +4 |
| NCT04528719 | A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive | PHASE1 | COMPLETED | 651 | — | — | Sep 30, 2020 | Jul 18, 2024 | Aug 7, 2024 | 31 | United States |
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 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.
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.
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.
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.
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. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Austria 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.
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.
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.
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.
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.
Seroresponse was defined as ≥4 × lower limit of quantification (LLOQ) if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
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.
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 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.
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.
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.
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.
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.
Seroresponse was defined as ≥4 × LLOQ if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.
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.
Seroresponse was defined as ≥4 × LLOQ if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. mRNA-As prespecified, only arms where participants received mRNA-1273.214 are presented for this outcome measure.
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.
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.
A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner.
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.
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.
Pregnancy outcomes will include stillbirth, live birth, vaginal delivery, and cesarean section delivery.
Birth outcomes will include gestational age and anthropometric measurements.
VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100\*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).
VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100\*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).
| Arm | Type | Description |
|---|---|---|
| mRNA-1345 | EXPERIMENTAL | Participants will receive a single dose of mRNA-1345 injection administered intramuscularly on Day 1. |
| Part A: mRNA-1345 Dose 1 | EXPERIMENTAL | Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1. |
| Part A: mRNA-1345 Dose 2 | EXPERIMENTAL | Single injection of mRNA-1345 administered IM on Day 1. |
| Part B: mRNA-1345 Dose 2 | EXPERIMENTAL | Two injections of mRNA-1345 administered IM on Day 1 and Day 57. |
| Fluzone HD + mRNA-1345 | EXPERIMENTAL | Participants will receive Fluzone HD + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22. |
| Fluzone HD Followed by mRNA-1345 | EXPERIMENTAL | Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22. |
| Part A: mRNA-1345 + Placebo | EXPERIMENTAL | Single injection of mRNA-1345 and placebo, administered intramuscularly (IM), one in each arm on Day 1. |
| Part A: mRNA-1345 + Afluria® Quadrivalent | EXPERIMENTAL | Single injection of mRNA-1345 and Afluria® quadrivalent, administered IM, one in each arm on Day 1. |
| Part A: Afluria® Quadrivalent + Placebo | ACTIVE_COMPARATOR | Single injection of Afluria® quadrivalent and placebo, administered IM, one in each arm on Day 1. |
| 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. |
| 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. |
| Part B: mRNA-1273.214 + Placebo | ACTIVE_COMPARATOR | 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. |
| Part C: mRNA-1345 | EXPERIMENTAL | Single injection of mRNA-1345 administered IM on BD Day 1. |
| mRNA-1345 Dose A | EXPERIMENTAL | Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single intramuscular (IM) injection of mRNA-1345 Dose A. |
| mRNA-1345 Dose B | EXPERIMENTAL | Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose B. |
| mRNA-1345 Dose C | EXPERIMENTAL | Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose C. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive single IM injection of mRNA-1345 vaccine matching placebo in the period from 28 weeks to 36 weeks of gestation. |
| Part A and Part B: Cohort 1 (2 to <5 Years of Age) | EXPERIMENTAL | Part A: Participants 2 to \<5 years of age will receive either a single intramuscular (IM) injection of mRNA-1345 or placebo on Day 1. Part B: Participants will have the option to be re-enrolled into a 6-month safety-follow up period. |
| Part A: Cohort 2 (5 to <18 Years of Age) | EXPERIMENTAL | Participants 5 to \<18 years of age will receive a single IM injection of mRNA-1345 on Day 1. |
| mRNA-1345 BD | EXPERIMENTAL | Single injection of mRNA-1345 on BD Day 1. |
| Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months) | EXPERIMENTAL | Participants will receive mRNA-1345 vaccine by intramuscular (IM) injection on Days 1, 57 and 113. |
| Part A: mRNA-1365, Dose 1 (Age Group: 8 to <24 months) | EXPERIMENTAL | Participants will receive mRNA-1365 vaccine by IM injection on Days 1, 57 and 113. |
| Part A: Placebo (Age Group: 8 to <24 months) | PLACEBO_COMPARATOR | Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113. |
| Part B: mRNA-1345, Dose 2 (Age Group: 5 to <8 months) | EXPERIMENTAL | Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113. |
| Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months) | EXPERIMENTAL | Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113. |
| Part B: mRNA-1345 Dose 1 (Age Group: 5 to <8 months) | EXPERIMENTAL | Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113. |
| Part B: mRNA-1365 Dose 1 (Age Group: 5 to <8 months) | EXPERIMENTAL | Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113. |
| Part B: Placebo (Age Group: 5 to <8 months) | PLACEBO_COMPARATOR | Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113. |
| Part C: mRNA-1345 Dose 1 (Age Group 8 to <12 months exposed to nirsevimab) | EXPERIMENTAL | Participants who have been previously exposed to nirsevimab will receive mRNA 1345 by IM on Days 1, 57, and 113. |
| Part C: mRNA-1345 Dose 1 (Age Group 8 to <12 months not exposed to nirsevimab) | EXPERIMENTAL | Participants who have not been previously exposed to nirsevimab will receive mRNA 1345 by IM on Days 1, 57, and 113. |
| Cohort 1: Dose A in Younger Adults | EXPERIMENTAL | Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1. |
| Cohort 2: Dose B in Younger Adults | EXPERIMENTAL | Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1. |
| Cohort 3: Dose B in Younger Adults | EXPERIMENTAL | Three total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113. |
| Cohort 4: Dose C in Younger Adults | EXPERIMENTAL | Single injection of Dose C of mRNA-1345 or matching-placebo on Day 1. |
| Cohort 5: Dose D in Children | EXPERIMENTAL | Three total injections, 1 injection of either Dose D of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113. |
| Cohort 6: Dose G in Children | EXPERIMENTAL | Three total injections, 1 injection of either Dose G of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113. |
| Cohort 7: Dose A in Older Adults | EXPERIMENTAL | Two total injections, 1 injection of either Dose A of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
| Cohort 8: Dose B in Older Adults | EXPERIMENTAL | Two total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
| Cohort 9: Dose C in Older Adults | EXPERIMENTAL | Two total injections, 1 injection of either Dose C of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
| Cohort 10: Dose E in Older Adults | EXPERIMENTAL | Two total injections, 1 injection of either Dose E of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
| Cohort 11: Dose F in Older Adults | EXPERIMENTAL | Two total injections, 1 injection of either Dose F of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
| Cohort 12: Dose E in Women of Child-Bearing Potential | EXPERIMENTAL | Single injection of Dose E of mRNA-1345 or matching-placebo on Day 1. |
| Cohort 13: Dose F in Women of Child-Bearing Potential | EXPERIMENTAL | Single injection of Dose F of mRNA-1345 or matching-placebo on Day 1. |
| Cohort 14: Dose A in Women of Child-Bearing Potential | EXPERIMENTAL | Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1. |
| Cohort 15: Dose B in Japanese Older Adults | EXPERIMENTAL | Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| mRNA-1345 | BIOLOGICAL | Suspension for injection |
| Placebo | BIOLOGICAL | 0.9% sodium chloride (normal saline) injection |
| Fluzone HD | BIOLOGICAL | Suspension for injection |
| Afluria® Quadrivalent | BIOLOGICAL | single-dose, pre-filled syringe for injection |
| mRNA-1273.214 | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1365 | BIOLOGICAL | Sterile liquid for injection |
| Nimenrix | DRUG | Solution for injection |
Key Inclusion Criteria: * Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by: * Absence of changes in medical therapy within 60 days of Visit 1 due to treatment failure or toxicity. * Absence of serious or significant medical events withi...