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mRNA-1345

Phase 3

Respiratory Syncytial Virus | Monoclonal antibody | Respiratory |Moderna, Inc.|Last Updated: May 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials9
Total Enrollment45,234
FDA Designations
No designations recorded
Clinical Trials (9)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07117487A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in Adult Participants ≥60 Years of AgePHASE3 COMPLETED 507Aug 5, 2025Mar 27, 2026May 4, 202611 United States
NCT06067230A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk AdultsPHASE3 ACTIVE NOT_RECRUITING 1,153Oct 6, 2023Jul 30, 2026Aug 8, 202544 United States, Canada +2
NCT06060457A 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 AgePHASE3 COMPLETED 1,900Sep 25, 2023Jun 7, 2024Jul 30, 202534 United States
NCT05330975A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of AgePHASE3 COMPLETED 3,317Apr 1, 2022Nov 8, 2024Dec 30, 202562 United States
NCT06143046A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated MothersPHASE2 ACTIVE NOT_RECRUITING 360Nov 15, 2023May 27, 2026Feb 5, 202656 United States, Canada +6
NCT06097299A 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 VirusPHASE2 COMPLETED 346Oct 24, 2023Jun 27, 2025Jul 10, 202550 United States, Panama
NCT05127434A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of AgePHASE2 COMPLETED 36,814Nov 17, 2021Jul 28, 2025Aug 19, 2025269 United States, Argentina +21
NCT05743881A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 MonthsPHASE1 ACTIVE NOT_RECRUITING 186Feb 15, 2023Sep 30, 2026Nov 24, 202550 United States, Australia +4
NCT04528719A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-SeropositivePHASE1 COMPLETED 651Sep 30, 2020Jul 18, 2024Aug 7, 202431 United States
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Study Endpoints
Primary Endpoints
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Day 1 up to Day 7 (7 days post-injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Day 1 up to Day 28 (28 days post-injection)
Number of Participants with Medically Attended AEs (MAAEs), Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation
Day 1 up to Day 181 (End of study)
Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29
Day 29
GMT of Serum RSV-B Neutralizing Abs at Day 29
Day 29
Number of Participants With Medically Attended AEs (MAAEs)
Day 1 through Month 6 (for Part A) and Day 1 through Month 9 (for Part B)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
Day 1 through End of Study (Day 730)
Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (Abs) at Day 29
Day 29
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85
Day 85
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
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.

Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection
Within 7 days after Day 22 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.

Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection
Up to 21 days 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.

Number of Participants With Unsolicited AEs Up to 21 Days After Day 22 Injection
Up to 21 days after Day 22 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.

Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Day 1 through Day 202

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.

Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (nAbs)
Day 22 (for Arm 1) and Day 43 (for Arm 2)

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.

GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay
Day 22

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.

Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
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.

Part A: Number of Participants With Unsolicited Adverse Events (AEs) After Day 1 Injection
Day 1 through Day 28 (28 days 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.

Part A: Number of Participants With Medically Attended AEs (MAAEs), SAEs, Adverse Events of Special Interest (AESIs), and AEs Leading to Withdrawal
Day 1 through Day 181 (end of Study Part A)

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.

Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) Neutralizing Antibodies (NAbs) at Day 29
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.

Part A: Percentage of Participants With Seroresponse in RSV-A NAbs at Day 29
Day 29

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.

Part A: GMT of Serum Anti-hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29
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.

Part B: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 1 Injection
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.

Part B: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 29 Injection
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: Number of Participants With Unsolicited AEs After Day 1 Injection
Day 1 through Day 28 (28 days 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.

Part B: Number of Participants With Unsolicited AEs After Day 29 Injection
Day 29 through Day 57 (28 days 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.

Part B: Number of Participants With MAAEs, SAEs, AESIs, and AEs Leading to Withdrawal
Day 1 through Day 211

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.

Part B: GMT of Serum RSV-A at Day 29
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.

Part B: Percentage of Participants With Seroresponse for RSV-A Neutralizing Abs From Baseline to Day 29
Baseline to Day 29

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.

Part B: Geometric Mean Concentration (GMC) of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 29
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.

Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs From Baseline to Day 29
Baseline to Day 29

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.

Part C: Number of Participants With Solicited Local and Systemic Within 7 Days After Revaccination Day 1
Within 7 days after Day 1 revaccination

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.

Part C: Number of Participants With Unsolicited AEs Within 28 Days After Revaccination Day 1
Revaccination Day 1 through Day 28 (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.

Part C: Number of Participants With MAAEs
Revaccination Day 1 through Day 181

A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner.

Part C: Number of Participants With SAEs, AESIs, and AEs Leading to Withdrawal
Revaccination Day 1 through Day 361

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.

Part C: GMT of Serum RSV-A and RSV-B NAbs mRNA-1345 Revaccination Day 29 Compared to Primary Vaccination Day 29
Primary Vaccination Day 29 to Revaccination 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.

Number of Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Up to Day 7 (7 days post vaccination)
Number of Maternal Participants with Unsolicited Adverse Events (AEs)
Up to Day 28 (28 days post vaccination)
Number of Maternal Participants with Medically-Attended AEs (MAAEs)
Day 1 to Month 6 (6 months postdelivery)
Number of Maternal Participants with Adverse Events of Special Interest (AESIs)
Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with Serious Adverse Events (SAEs)
Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with AEs Leading to Discontinuation
Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants With Pregnancy Outcomes
Day 1 to Month 12 (12 months postdelivery)

Pregnancy outcomes will include stillbirth, live birth, vaginal delivery, and cesarean section delivery.

Number of Infant Participants with MAAEs
Day 1 (birth) to Month 12
Number of Infant Participants with AESIs
Day 1 (birth) to Month 12
Number of Infant Participants with SAEs
Day 1 (birth) to Month 12
Number of Infant Participants With Birth Outcomes
Day 1 (birth) to Month 12

Birth outcomes will include gestational age and anthropometric measurements.

Part A: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Up to 7 days postinjection
Part A: Number of Participants with Unsolicited Adverse Events (AEs)
Up to 28 days postinjection
Part A: Number of Participants With Medically Attended AEs (MAAEs)
Day 1 through end of study (EOS; Month 6)
Part A: Number of Participants With Adverse Events of Special Interest (AESIs)
Day 1 through EOS (Month 6)
Part A: Number of Participants With Serious Adverse Events (SAEs)
Day 1 through EOS (Month 6)
Part A: Number of Participants With AEs Leading to Discontinuation
Day 1 through EOS (Month 6)
Part B: Number of participants With Respiratory syncytial virus-Respiratory tract disease (RSV-RTD), Respiratory syncytial virus- Lower Respiratory tract disease (RSV-LRTD), Severe RSV-LRTD, Very Severe RSV-LRTD and RSV Hospitalization
Day 1 through EOS (Month 6)
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Withdrawal
Up to BD Day 181
Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms
From 14 days postinjection up to 12 months postinjection

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 a First Episode of RSV-LRTD with 3 or More Symptoms
From 14 days postinjection up to 12 months postinjection

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).

Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies
BD Day 29
Geometric Mean Ratio (GMR) of Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose
BD Day 29
Number of Participants with Medically-Attended Adverse Events (MAAEs)
Day 1 through Day 730
Number of Participants with Adverse Event of Special Interests (AESIs), Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation
Day 1 through Day 730
Number of Participants with Serious AEs or Medically Attended AEs (MAAEs)
Up to Day 1095 (End of Study)
Secondary Endpoints
GMT of Serum RSV-A Neutralizing Abs
Day 1 up to Day 181 (End of study)
Geometric Mean Fold Rise (GMFR) of Serum RSV-A Neutralizing Abs
Day 181
GMT of Serum RSV-B Neutralizing Abs
Day 1 up to Day 181 (End of study)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
mRNA-1345EXPERIMENTALParticipants will receive a single dose of mRNA-1345 injection administered intramuscularly on Day 1.
Part A: mRNA-1345 Dose 1EXPERIMENTALSingle injection of mRNA-1345 administered intramuscularly (IM) on Day 1.
Part A: mRNA-1345 Dose 2EXPERIMENTALSingle injection of mRNA-1345 administered IM on Day 1.
Part B: mRNA-1345 Dose 2EXPERIMENTALTwo injections of mRNA-1345 administered IM on Day 1 and Day 57.
Fluzone HD + mRNA-1345EXPERIMENTALParticipants 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-1345EXPERIMENTALParticipants 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 + PlaceboEXPERIMENTALSingle injection of mRNA-1345 and placebo, administered intramuscularly (IM), one in each arm on Day 1.
Part A: mRNA-1345 + Afluria® QuadrivalentEXPERIMENTALSingle injection of mRNA-1345 and Afluria® quadrivalent, administered IM, one in each arm on Day 1.
Part A: Afluria® Quadrivalent + PlaceboACTIVE_COMPARATORSingle injection of Afluria® quadrivalent and placebo, administered IM, one in each arm on Day 1.
Part B: mRNA-1345 + PlaceboEXPERIMENTALSingle 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-1273.214EXPERIMENTALSingle 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 + PlaceboACTIVE_COMPARATORSingle 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-1345EXPERIMENTALSingle injection of mRNA-1345 administered IM on BD Day 1.
mRNA-1345 Dose AEXPERIMENTALParticipants 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 BEXPERIMENTALParticipants 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 CEXPERIMENTALParticipants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose C.
PlaceboPLACEBO_COMPARATORParticipants 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)EXPERIMENTALPart 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)EXPERIMENTALParticipants 5 to \<18 years of age will receive a single IM injection of mRNA-1345 on Day 1.
mRNA-1345 BDEXPERIMENTALSingle injection of mRNA-1345 on BD Day 1.
Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants will receive mRNA-1365 vaccine by IM injection on Days 1, 57 and 113.
Part A: Placebo (Age Group: 8 to <24 months)PLACEBO_COMPARATORParticipants 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)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants will receive mRNA-1365 by IM injection on Days 1, 57 and 113.
Part B: Placebo (Age Group: 5 to <8 months)PLACEBO_COMPARATORParticipants 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)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants 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 AdultsEXPERIMENTALSingle injection of Dose A of mRNA-1345 or matching-placebo on Day 1.
Cohort 2: Dose B in Younger AdultsEXPERIMENTALSingle injection of Dose B of mRNA-1345 or matching-placebo on Day 1.
Cohort 3: Dose B in Younger AdultsEXPERIMENTALThree 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 AdultsEXPERIMENTALSingle injection of Dose C of mRNA-1345 or matching-placebo on Day 1.
Cohort 5: Dose D in ChildrenEXPERIMENTALThree 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 ChildrenEXPERIMENTALThree 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 AdultsEXPERIMENTALTwo 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 AdultsEXPERIMENTALTwo 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 AdultsEXPERIMENTALTwo 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 AdultsEXPERIMENTALTwo 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 AdultsEXPERIMENTALTwo 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 PotentialEXPERIMENTALSingle injection of Dose E of mRNA-1345 or matching-placebo on Day 1.
Cohort 13: Dose F in Women of Child-Bearing PotentialEXPERIMENTALSingle injection of Dose F of mRNA-1345 or matching-placebo on Day 1.
Cohort 14: Dose A in Women of Child-Bearing PotentialEXPERIMENTALSingle injection of Dose A of mRNA-1345 or matching-placebo on Day 1.
Cohort 15: Dose B in Japanese Older AdultsEXPERIMENTALSingle injection of Dose B of mRNA-1345 or matching-placebo on Day 1.
Interventions
NameTypeDescription
mRNA-1345BIOLOGICALSuspension for injection
PlaceboBIOLOGICAL0.9% sodium chloride (normal saline) injection
Fluzone HDBIOLOGICALSuspension for injection
Afluria® QuadrivalentBIOLOGICALsingle-dose, pre-filled syringe for injection
mRNA-1273.214BIOLOGICALSterile liquid for injection
mRNA-1365BIOLOGICALSterile liquid for injection
NimenrixDRUGSolution for injection
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites11

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...

Countries:United StatesCanadaPuerto RicoUnited KingdomChileDenmarkJapanPanamaSouth AfricaArgentinaAustraliaBangladeshBelgiumColombiaCosta RicaFinlandGermanyMexicoNew ZealandPolandSingaporeSouth KoreaSpainTaiwan
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Recent Changes (Last 90 Days)
MEDIUMJun 4, 2026NCT07117487TRIAL_REMOVED: changed
MEDIUMJun 4, 2026NCT07117487TRIAL_REMOVED: changed
MEDIUMJun 4, 2026NCT07117487TRIAL_REMOVED: changed
MEDIUMJun 4, 2026NCT07117487TRIAL_REMOVED: changed
MEDIUMJun 4, 2026NCT07117487TRIAL_REMOVED: changed
LOWMay 26, 2026NCT05743881primaryCompletionDate: changed
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LOWMay 26, 2026NCT06143046primaryCompletionDate: changed
HIGHMay 26, 2026NCT07117487Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 24, 2026NCT05743881studyFirstPostDate: changed
LOWMay 24, 2026NCT06143046studyFirstPostDate: changed
LOWMay 24, 2026NCT06067230studyFirstPostDate: changed
LOWMay 24, 2026NCT07117487studyFirstPostDate: changed