A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age

NCT05330975
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Phase
Phase 3
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Recruitment status
Completed
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Participants
3,317
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Lead sponsor
ModernaTX, Inc.
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Start date
2022-04-01
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Number of sites
62
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Summary
The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza. The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose.
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Acronym
RSVictory
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Short title
A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age
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Official title
A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered With a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given as an Open-label Boost at 1 Year Following a Primary Dose in Adults ≥ 50 Years of Age
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Control arm
Active comparator
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2024-11-08
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First posted
2022-04-15
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Registry last updated
2025-12-30
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Primary completion date
2024-11-08
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Start date
2022-04-01
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Actual participants
3,317
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Participants
3,317
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
62
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
ModernaTX, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05330975
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ClinicalTrials.gov ID
NCT05330975
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masking description
Parts A and B are randomized, observer blind studies and Part C is a single-arm, open-label study.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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.

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

    Timeframe: 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.

  3. Part A: Number of Participants With Medically Attended AEs (MAAEs), SAEs, Adverse Events of Special Interest (AESIs), and AEs Leading to Withdrawal

    Timeframe: 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.

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

    Timeframe: 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.

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

    Timeframe: 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.

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

    Timeframe: 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.

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

    Timeframe: 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.

  8. Part B: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 29 Injection

    Timeframe: 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.

  9. Part B: Number of Participants With Unsolicited AEs After Day 1 Injection

    Timeframe: 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.

  10. Part B: Number of Participants With Unsolicited AEs After Day 29 Injection

    Timeframe: 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.

  11. Part B: Number of Participants With MAAEs, SAEs, AESIs, and AEs Leading to Withdrawal

    Timeframe: 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.

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

    Timeframe: 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.

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

    Timeframe: 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.

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

    Timeframe: 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.

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

    Timeframe: 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.

  16. Part C: Number of Participants With Solicited Local and Systemic Within 7 Days After Revaccination Day 1

    Timeframe: 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.

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

    Timeframe: 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.

  18. Part C: Number of Participants With MAAEs

    Timeframe: Revaccination Day 1 through Day 181

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

  19. Part C: Number of Participants With SAEs, AESIs, and AEs Leading to Withdrawal

    Timeframe: 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.

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

    Timeframe: 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.

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

    Timeframe: Day 29

    Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

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

    Timeframe: 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.

  3. Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains at Day 181

    Timeframe: Day 181

    Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Seroconversion was defined as a titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline in the titers if Baseline was ≥1:10. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.

  4. Part A: GMT of Serum RSV-A and RSV-B NAbs at Day 181

    Timeframe: Day 181

    Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  5. Part A: Geometric Mean Fold Rise (GMFR) of Serum RSV-A and RSV-B NAbs at Day 181

    Timeframe: Day 181

    95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  6. Part A: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 181

    Timeframe: Day 181

    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.

  7. Part A: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 181

    Timeframe: Baseline to Day 181

    ≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 \* LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  8. Part A: GMT of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181

    Timeframe: Day 181

    Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.

  9. Part A: GMFR of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181

    Timeframe: Day 181

    Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B. 95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.

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

    Timeframe: Day 29

    Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  11. Part B: Percentage of Participants With Seroresponse in RSV-B NAbs From Baseline to Day 29

    Timeframe: 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.

  12. Part B: GMT of Serum RSV-A and RSV-B NAbs at Day 181

    Timeframe: Day 181

    Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  13. Part B: GMFR of Serum RSV-A and RSV-B NAbs at Day 181

    Timeframe: Day 181

    Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  14. Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 181

    Timeframe: Day 181

    95% CI for GM value was calculated based on the t-distribution of the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. SARS-CoV-2 variants included Wuhan-Hu-1 and B.1.1.529. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for Wuhan-Hu-1. LLOQ was 8 AU/mL and ULOQ was 24503 for B1.1.529.

  15. Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 181

    Timeframe: Day 181

    95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.

  16. Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs From Baseline to Day 181

    Timeframe: Baseline to Day 181

    Seroresponse was defined as ≥4 × LLOQ if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. 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 and ULOQ was 111433 for Wuhan-Hu-1. LLOQ was 8 and ULOQ was B.1.1.529 for B1.1.529.

  17. Part B: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 181

    Timeframe: Day 181

    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.

  18. Part B: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 181

    Timeframe: Baseline to Day 181

    ≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 \* LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  19. Part B: GMT of Serum RSV-A and RSV-B NAbs at Day 211

    Timeframe: Day 211

    Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  20. Part B: GMFR of Serum RSV-A and RSV-B NAbs at Day 211

    Timeframe: Day 211

    Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  21. Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 211

    Timeframe: Day 211

    95% CI for GM value was calculated based on the t-distribution of the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. SARS-CoV-2 variants included Wuhan-Hu-1 and B.1.1.529. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for Wuhan-Hu-1. LLOQ was 8 AU/mL and ULOQ was 24503 for B1.1.529.

  22. Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 211

    Timeframe: Day 211

    95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.

  23. Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs at Day 211

    Timeframe: Day 211

    Seroresponse was defined as ≥4 × LLOQ if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. 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 and ULOQ was 111433 for Wuhan-Hu-1. LLOQ was 8 and ULOQ was B.1.1.529 for B1.1.529.

  24. Part B: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 211

    Timeframe: Day 211

    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.

  25. Part B: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 211

    Timeframe: Day 211

    ≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 \* LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

And 5 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
50 Years
Healthy volunteers
Yes

Key Inclusion Criteria:

Parts A and B both:

  • Adults ≥50 years of age on the day of the Randomization Visit (Day 1) who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by: Absence of changes in medical therapy within 1 month due to treatment failure or toxicity; Absence of medical events qualifying as SAEs within 1 month of the planned vaccination on Day 1; and absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator, would make completion of the protocol unlikely.
  • Able to comply with study requirements, including access to transportation for study visits.

Part B only:

  • Fully vaccinated for COVID-19 with an approved primary series according to the locally authorized or approved regimen. If the most recent COVID-19 vaccine was part of a primary series, it must be ≥ 150 days before (or less per local guidance) Day 1. If the most recent COVID-19 vaccine was a booster dose, it must be ≥ 120 days before (or less per local guidance) Day 1.

Part C:

  • Participants at Part C study sites who have been enrolled in Part B (Groups 4 and 5) of this study; have immunogenicity blood sampling at Part B baseline and Day 29; completed the Day 211/end-of-study visits for Part B; were included in the per-protocol (PP) set; and received 1 dose of mRNA-1345 at least 12 months (but no later than 15 months) prior to the time of enrollment.
  • Able to comply with study requirements, including access to transportation for study visits.

Key Exclusion Criteria:

Part A:

  • Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
  • Prior participation in research involving receipt of any investigational product (drug/biologic/device including any investigational RSV product) within 45 days before the planned date of the Day 1 study injection.
  • Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤180 days prior to the Randomization Visit (Day 1).
  • History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
  • Participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

Part B:

  • Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤ 28 days prior to study injections (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections (with the exception of SARS-Cov-2 vaccination).
  • Prior participation in research involving receipt of any investigational product (drug/biologic/device with the exception of RSV investigation products) within 45 days before the planned date of the Day 1 study injection.
  • Prior receipt of any investigational/approved RSV product within 1 year of the Day 1 study injection.
  • Has known history of SARS-CoV-2 infection within 90 days prior to enrollment.

Parts A and B both:

  • Participant had significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 10 days, as defined by the United States (US) Centers for Disease Control and Prevention (CDC) as a close contact of someone who has had COVID-19.

Part C:

  • Participation in another interventional clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of the BD Day 1 study injection. Any prior receipt of an investigational or approved vaccine against RSV, except as part of mRNA-1345 Study P302 Part B, is exclusionary.
  • Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to the study injection (BD Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
  • History of a serious reaction to any prior vaccination or Guillain-Barré syndrome 6 weeks after any prior influenza immunization.

Other inclusion and/or exclusion criteria may apply.

Sources for eligibility
clinicaltrials.gov

  • Central Research Associates IncBirmingham, United States
  • Del Sol Research Management - Clinedge - PPDSTucson, United States
  • Paragon Rx Clinical, IncGarden Grove, United States
  • Ark Clinical ResearchLong Beach, United States
  • Long Beach Clinical Trials, LLC (Site 1)Long Beach, United States
  • Long Beach Clinical Trials, LLC (Site 2)Long Beach, United States
  • Central Valley Research, LLCModesto, United States
  • Velocity Clinical Research - Panorama CityPanorama City, United States
  • Empire Clinical ResearchPomona, United States
  • Acclaim Clinical ResearchSan Diego, United States
  • Medical Center For Clinical Research - M3 WR - ERN - PPDSSan Diego, United States
  • Ark Clinical ResearchTustin, United States
  • Chase Medical Research LLCWaterbury, United States
  • Teradan Clinical TrialsBrandon, United States
  • Revival Research Corporation - Clinedge - PPDSDoral, United States
  • Dolphin Medical ResearchDoral, United States
  • Indago Research and Health CenterHialeah, United States
  • Westside Center for Clinical Research - ERN - PPDSJacksonville, United States
  • Suncoast Research Group LLC - ERN-PPDSMiami, United States
  • Suncoast Research Associates LLC - ERN - PPDSMiami, United States
  • Floridian Clinical Research - ClinEdge - PPDSMiami Lakes, United States
  • Tekton Research - Georgia - Platinum - PPDSChamblee, United States
  • Lifeline Primary Care / CCT ResearchLilburn, United States
  • Georgia Clinic / CCT ResearchNorcross, United States
  • Meridian Clinical Research (Savannah Georgia) - Platinum - PPDSSavannah, United States

And 37 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)