Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as mRNA-1345 (Profile 1)
mRNA-1345 · 9 trials · 2 indications
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.
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 was an AE that led to an unscheduled visit to a healthcare practitioner. An AESI was 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.
RSV-RTD: Runny nose or blocked nose or cough and confirmed RSV infection. RSV-LRTD: Cough or difficulty breathing (Based on Investigator's observation; difficulty breathing included signs of wheezing, stridor, tachypnoea, chest in-drawing or subcostal or intercostal retractions) and peripheral oxygen saturation (SpO2) \<95%, or respiratory rate (RR) increased and confirmed RSV infection. RSV Severe-LRTD: Meeting the definition of RSV-LRTD and SpO2 \<93%, or lower chest wall in-drawing. RSV Very Severe LRTD: Meeting the definition of RSV-LRTD and SpO2 \<90%, or failure to respond/unconscious. RSV Hospitalization: Confirmed RSV and hospitalized for acute medical condition.
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 recorded daily using electronic diaries (eDiaries). 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 all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
MAAEs were AEs that led to an unscheduled visit to a healthcare provider. AESIs were AEs (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 was required. SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
MAAEs were AEs that led to an unscheduled visit to a healthcare provider. AESIs were AEs (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 was required. SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
RSV-LRTD: Reverse transcriptase polymerase chain reaction (RT PCR) confirmed RSV infection PLUS new or worsening of ≥2 of the following symptoms: shortness of breath, cough and/or fever (≥37.8 degrees Celsius \[°C\]), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours.
RSV-LRTD: RT PCR confirmed RSV infection PLUS new or worsening of ≥3 of the following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours.
Antibody values reported as below lower limit of quantification (LLOQ) replaced by 0.5 \* LLOQ. Values greater than upper limit of quantification (ULOQ) replaced by ULOQ. LLOQ = 13 international units (IU)/milliliter (mL), ULOQ = 259061 IU/mL for RSV-A nAb. LLOQ = 10, ULOQ = 112476 for RSV-B nAb. Part B Per-protocol (PP) Set: all Part B randomized participants who received both Parts A and B assigned study intervention doses, had RSV immunogenicity titer results at pre-Primary Dose (baseline), had RSV immunogenicity titer results at Primary Dose Day 29, had at least 1 valid result at Revaccination Day 29, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the study intervention group to which they were randomized.
| 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 B Extension: mRNA-1345, Dose 2 (Age Group: 5 to <8 months) | NO_INTERVENTION | Participants will have the option to re-enrol in the Part B extension period. |
| Part B Extension: mRNA-1365, Dose 2 (Age Group: 5 to <8 months) | NO_INTERVENTION | Participants will have the option to re-enrol in the Part B extension period. |
| Part B Extension: mRNA-1345 Dose 1 (Age Group: 5 to <8 months) | NO_INTERVENTION | Participants will have the option to re-enrol in the Part B extension period. |
| Part B Extension: mRNA-1365 Dose 1 (Age Group: 5 to <8 months) | NO_INTERVENTION | Participants will have the option to re-enrol in the Part B extension period. |
| Part B Extension : Placebo (Age Group: 5 to <8 months) | NO_INTERVENTION | Participants will have the option to re-enrol in the Part B extension period. |
| 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 injection 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 injection 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...
mRNA-1345 is an investigational mRNA vaccine developed by Moderna, Inc. for the prevention of respiratory syncytial virus, or RSV. It is designed for use in older adults and other populations at risk of RSV disease. It is currently in Phase 3 clinical development and has not been approved by the FDA.
mRNA-1345 is being developed to prevent respiratory syncytial virus, or RSV, in older adults and other at-risk groups. Clinical studies have evaluated it in adults aged 60 and older, high-risk adults, pregnant women, and children at high risk of RSV. It remains an investigational vaccine.
mRNA-1345 is developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the clinical program evaluating the vaccine across multiple age groups and risk populations, including older adults, pregnant women, and children.
mRNA-1345 is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. The program includes nine total trials, of which eight are completed and one remains active, with a combined enrollment of more than 45,000 participants.
mRNA-1345 has been studied in nine trials, including NCT07117487, a Phase 3 study of the vaccine following a primary dose of a licensed protein subunit RSV vaccine in adults 60 and older, and NCT06067230, a Phase 3 immunogenicity and safety study in high-risk adults. Earlier Phase 2 studies included NCT06143046 in pregnant women and infants, and NCT06097299 in children aged 2 to under 18 at high risk of RSV.
Yes. mRNA-1345 (Profile 1) refers to the same investigational RSV vaccine candidate from Moderna, Inc. that is known as mRNA-1345. The parenthetical label is an alternate identifier for the same asset, so searches for either name point to the same Phase 3 program.