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The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in adults ≥65 years of age. The study will examine the impact of Fluzone HD on the immune response to mRNA-1345 against RSV-A and RSV-B, as well as the impact of mRNA-1345 on the immune response to Fluzone HD against 4 vaccine-matched Influenza A and B strains.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | 0.9% sodium chloride (normal saline) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection | Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. | Within 7 days after Day 1 injection |
| Number of Participants With Solicited Local and Systemic ARs 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. | Within 7 days after Day 22 injection |
| Number of Participants With Unsolicited Adverse Events (AEs) 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroresponse for RSV-A and RSV-B nAbs, as Measured by HAI Assay | Seroresponse at a participant level was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. | Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Deaths Related to Study Drug | A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause. |
Key Inclusion Criteria:
Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by:
A participant assigned female at birth is eligible to participate if they are postmenopausal or not a person of childbearing potential.
Key Exclusion Criteria:
Note: Other protocol-defined inclusion and/or exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Clinical Trials | Scottsdale | Arizona | 85258 | United States | ||
| Headlands Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42048601 | Derived | Comstock E, Fogarty C, Caso J, Vu J, Sinha A, Cao X, Chen H, Rushton L, Ma C, Priddy F. Coadministration of mRNA-1345 RSV vaccine with high-dose quadrivalent influenza vaccine in adults aged 65 and older: An observer-blinded, placebo-controlled, randomized, phase 3 trial. Hum Vaccin Immunother. 2026 Dec;22(1):2649335. doi: 10.1080/21645515.2026.2649335. Epub 2026 Apr 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluzone HD + mRNA-1345 Followed by Placebo | Participants received Fluzone High Dose (HD) + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22. |
| FG001 | Fluzone HD + Placebo Followed by mRNA-1345 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2023 | Jun 5, 2025 |
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| mRNA-1345 | Biological | Suspension for injection |
|
| Fluzone HD | Biological | Suspension for injection |
|
| Up to 21 days after Day 1 injection |
| Number of Participants With Unsolicited AEs 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. | Up to 21 days after Day 22 injection |
| Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation | A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. | Day 1 through Day 202 |
| Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (nAbs) | 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. | Day 22 (for Arm 1) and Day 43 (for Arm 2) |
| GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay | 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. | Day 22 |
| Geometric Mean Fold-Rise (GMFR) of Postinjection RSV-A and RSV-B nAbs Antibodies for Influenza, as Measured by HAI Assay | 95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. | Day 22 (for Arm 1) or Day 43 (for Arm 2) |
| Percentage of Participants With ≥2-fold Increase in RSV-A and RSV-B nAbs | ≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 * LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. | Day 22 (Arm 1) or Day 43 (Arm 2) |
| Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A strains included H1N1 and H3N2 and influenza B strains included Austria and Phuket strains. Seroconversion at a participant level was defined as a titer ≥1:40 if baseline is < 1:10 or at least a 4-fold increase from baseline if baseline was ≥1:10. 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. | Day 22 |
| GMFR of Serum Ab Level, as Measured by HAI Assay | 95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. | Day 22 |
| Day 1 through Day 202 |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| West Coast Research LLC | Dublin | California | 94568 | United States |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | United States |
| Peninsula Research Associates (PRA) | Rolling Hills Estates | California | 90274 | United States |
| Acclaim Clinical Research | San Diego | California | 92120 | United States |
| Neoclinical Research | Hialeah | Florida | 33016 | United States |
| Health Awareness INC | Jupiter | Florida | 33458 | United States |
| South Florida Research Center, Inc. | Miami | Florida | 33135 | United States |
| Suncoast Research Associates, LLC | Miami | Florida | 33173 | United States |
| Headlands Research - Orlando | Orlando | Florida | 32819 | United States |
| New Tampa Health, Inc | Tampa | Florida | 33603 | United States |
| Clinical Research Atlanta/Headlands | Stockbridge | Georgia | 30281 | United States |
| Bingham Memorial Hospital | Blackfoot | Idaho | 83221 | United States |
| DM Clinical Research- River Forest | River Forest | Illinois | 60305 | United States |
| Velocity Clinical Research-Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| DelRicht Research @ Neighborhood Health | Prairieville | Louisiana | 70769 | United States |
| DM Clinical Research - Brookline | Brookline | Massachusetts | 02445 | United States |
| DM Clinical Research - Southfield | Southfield | Michigan | 48076 | United States |
| Delricht Research at Gulfport Memorial | Gulfport | Mississippi | 39503 | United States |
| Delricht Research | Springfield | Missouri | 65807 | United States |
| Be Well Clinical Studies, LLC | Lincoln | Nebraska | 68516 | United States |
| Velocity Clinical Research-Norfolk | Norfolk | Nebraska | 68701 | United States |
| Trial Management Associates, LLC | Wilmington | North Carolina | 28403 | United States |
| Synexus AES - Akron | Akron | Ohio | 44311 | United States |
| Centricity Research | Columbus | Ohio | 43213 | United States |
| Delricht Tate | Tulsa | Oklahoma | 74133 | United States |
| DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| Delricht Moyer | Hendersonville | Tennessee | 37075 | United States |
| DM Clinical Research - Houston | Houston | Texas | 77065 | United States |
| DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE | McKinney | Texas | 75070 | United States |
| Javara Inc. /Privia Medical Group Gulf Coast, PLLC | Sugar Land | Texas | 77054 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22. |
| Received Day 1 Injection |
|
| Received Day 22 Injection |
|
| Safety Set | All randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Randomized Set included all participants who were randomized in the study, regardless of the participant's treatment status in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluzone HD + mRNA-1345 Followed by Placebo | Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22. |
| BG001 | Fluzone HD + Placebo Followed by mRNA-1345 | Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection | Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. | Day 1 Solicited Safety Set included all randomized participants who received any study intervention on Day 1 and contributed any solicited ARs data from the time of study injection on Day 1 through the following 6 days. Participants were included in the treatment arm corresponding to the study drug they actually received. | Posted | Count of Participants | Participants | Within 7 days after Day 1 injection |
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| Primary | Number of Participants With Solicited Local and Systemic ARs 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. | Day 22 Solicited Safety Set included all randomized participants who received any study intervention on Day 22 and contributed any solicited ARs data from the time of study injection on Day 22 through the following 6 days. Participants were included in the treatment arm corresponding to the study drug they actually received. | Posted | Count of Participants | Participants | Within 7 days after Day 22 injection |
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| Primary | Number of Participants With Unsolicited Adverse Events (AEs) 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. | The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received. | Posted | Count of Participants | Participants | Up to 21 days after Day 1 injection |
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| Primary | Number of Participants With Unsolicited AEs 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. | The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received. | Posted | Count of Participants | Participants | Up to 21 days after Day 22 injection |
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| Primary | Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation | A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. | The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received. | Posted | Count of Participants | Participants | Day 1 through Day 202 |
| |||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (nAbs) | 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. | The Per-protocol (PP) Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Day 22 (for Arm 1) and Day 43 (for Arm 2) |
| ||||||||||||||||||||||||||||||
| Primary | GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay | 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. | The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 22 |
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| Secondary | Percentage of Participants With Seroresponse for RSV-A and RSV-B nAbs, as Measured by HAI Assay | Seroresponse at a participant level was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. | The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2) |
| ||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Fold-Rise (GMFR) of Postinjection RSV-A and RSV-B nAbs Antibodies for Influenza, as Measured by HAI Assay | 95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. | The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 22 (for Arm 1) or Day 43 (for Arm 2) |
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| Secondary | Percentage of Participants With ≥2-fold Increase in RSV-A and RSV-B nAbs | ≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 * LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. | The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (Arm 1) or Day 43 (Arm 2) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Seroconversion, as Measured by HAI Assay | Influenza A strains included H1N1 and H3N2 and influenza B strains included Austria and Phuket strains. Seroconversion at a participant level was defined as a titer ≥1:40 if baseline is < 1:10 or at least a 4-fold increase from baseline if baseline was ≥1:10. 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. | The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 |
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| Secondary | GMFR of Serum Ab Level, as Measured by HAI Assay | 95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. | The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 22 |
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| Other Pre-specified | Number of Deaths Related to Study Drug | A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause. | The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received. | Posted | Count of Participants | Participants | Day 1 through Day 202 |
|
All-cause mortality and serious adverse events were collected Day 1 up to Day 202. Other (not including serious) unsolicited adverse events were collected up to 21 days after each study injection (that is, Day 1 up to Day 21 for the first injection and Day 22 up to Day 43 for the second injection).
All-cause mortality based on randomization set. SAEs and other (not including serious) AEs based on safety set (all randomized participants who received any study vaccination). Participants included in treatment arm corresponding to study drug they actually received. Per prespecified analysis, all-cause mortality, SAE, and other (not including serious) AE data were collected by arm assignment of "Fluzone HD + mRNA-1345 Followed by Placebo" or "Fluzone HD + Placebo Followed by mRNA-1345".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluzone HD + mRNA-1345 Followed by Placebo | Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22. | 2 | 950 | 23 | 947 | 0 | 947 |
| EG001 | Fluzone HD + Placebo Followed by mRNA-1345 | Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22. | 2 | 950 | 33 | 946 | 0 | 946 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Septic encephalopathy | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia stage 1 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Central cord syndrome | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 25.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Moderna WeCare Team | ModernaTX, Inc. | +1-866-663-3762 | WeCareClinicalTrials@modernatx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 10, 2023 | Jun 5, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722749 | mRNA-1345 respiratory syncytial virus vaccine |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22. |
|
|