Trial · NCT06060457
A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
NCT06060457, Phase 3, Completed, ModernaTX, Inc.; results first posted 2025-07-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age. Trials, record NCT06060457. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06060457
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
- NCT number
- NCT06060457
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,900 participants, actual
- Lead sponsor
- ModernaTX, Inc.
- Conditions
- Respiratory Syncytial Virus
- Interventions
- Placebo, mRNA-1345, Fluzone HD
- First posted
- 2023-09-29
- Last updated
- 2025-07-30
- Results first posted
- 2025-07-30
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection | Within 7 days after Day 1 injection | Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. |
| Primary | Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection | Within 7 days after Day 22 injection | Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. |
| Primary | Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection | Up to 21 days after Day 1 injection | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. |
| Primary | Number of Participants With Unsolicited AEs Up to 21 Days After Day 22 Injection | Up to 21 days after Day 22 injection | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or PT/PTT) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. |
| 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 | Day 1 through Day 202 | A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. |
| 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) | Day 22 (for Arm 1) and Day 43 (for Arm 2) | Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 international units (IU)/milliliter (mL) and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. |
| Primary | GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay | Day 22 | Influenza A strains included H1N1 and H3N2 and influenza B strains included Austria and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B. |
| Secondary | Percentage of Participants With Seroresponse for RSV-A and RSV-B nAbs, as Measured by HAI Assay | Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2) | 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. |
| Secondary | Geometric Mean Fold-Rise (GMFR) of Postinjection RSV-A and RSV-B nAbs Antibodies for Influenza, as Measured by HAI Assay | Day 22 (for Arm 1) or Day 43 (for Arm 2) | 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. |
| Secondary | Percentage of Participants With ≥2-fold Increase in RSV-A and RSV-B nAbs | Day 22 (Arm 1) or Day 43 (Arm 2) | ≥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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection | Within 7 days after Day 1 injection | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection | Within 7 days after Day 22 injection | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection | Up to 21 days after Day 1 injection | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Unsolicited AEs Up to 21 Days After Day 22 Injection | Up to 21 days after Day 22 injection | 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. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Day 1 through Day 202 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Day 22 (for Arm 1) and Day 43 (for Arm 2) | 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. | IU/mL | GEOMETRIC_MEAN |
| PRIMARY | GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay | Day 22 | 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. | titer | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Seroresponse for RSV-A and RSV-B nAbs, as Measured by HAI Assay | Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2) | 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. | percentage of participants | NUMBER |
| SECONDARY | Geometric Mean Fold-Rise (GMFR) of Postinjection RSV-A and RSV-B nAbs Antibodies for Influenza, as Measured by HAI Assay | Day 22 (for Arm 1) or Day 43 (for Arm 2) | 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. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With ≥2-fold Increase in RSV-A and RSV-B nAbs | Day 22 (Arm 1) or Day 43 (Arm 2) | 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. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection | Fluzone HD + mRNA-1345 Followed by Placebo | 689 | Participants | ||
| Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection | Fluzone HD + Placebo Followed by mRNA-1345 | 547 | Participants | ||
| Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection | Fluzone HD + mRNA-1345 Followed by Placebo | 251 | Participants | ||
| Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection | Fluzone HD + Placebo Followed by mRNA-1345 | 557 | Participants | ||
| Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection | Fluzone HD + mRNA-1345 Followed by Placebo | 72 | Participants | ||
| Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection | Fluzone HD + Placebo Followed by mRNA-1345 | 72 | Participants | ||
| Number of Participants With Unsolicited AEs Up to 21 Days After Day 22 Injection | Fluzone HD + mRNA-1345 Followed by Placebo | 60 | Participants | ||
| Number of Participants With Unsolicited AEs Up to 21 Days After Day 22 Injection | Fluzone HD + Placebo Followed by mRNA-1345 | 71 | Participants | ||
| Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation | Fluzone HD + mRNA-1345 Followed by Placebo | MAAEs | 194 | Participants | |
| Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation | Fluzone HD + Placebo Followed by mRNA-1345 | MAAEs | 191 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluzone HD + mRNA-1345 Followed by Placebo | 950 | |
| Overall Study | STARTED | Fluzone HD + Placebo Followed by mRNA-1345 | 950 | |
| Overall Study | Received Day 1 Injection | Fluzone HD + mRNA-1345 Followed by Placebo | 946 | |
| Overall Study | Received Day 1 Injection | Fluzone HD + Placebo Followed by mRNA-1345 | 947 | |
| Overall Study | Received Day 22 Injection | Fluzone HD + mRNA-1345 Followed by Placebo | 919 | |
| Overall Study | Received Day 22 Injection | Fluzone HD + Placebo Followed by mRNA-1345 | 911 | |
| Overall Study | Safety Set | Fluzone HD + mRNA-1345 Followed by Placebo | 947 | |
| Overall Study | Safety Set | Fluzone HD + Placebo Followed by mRNA-1345 | 946 | |
| Overall Study | COMPLETED | Fluzone HD + mRNA-1345 Followed by Placebo | 914 | |
| Overall Study | COMPLETED | Fluzone HD + Placebo Followed by mRNA-1345 | 909 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events134
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Bacterial sepsis | Infections and infestations | Fluzone HD + mRNA-1345 Followed by Placebo | 0 | 947 | 0 |
| serious | Bacterial sepsis | Infections and infestations | Fluzone HD + Placebo Followed by mRNA-1345 | 1 | 946 | 1 |
| serious | COVID-19 | Infections and infestations | Fluzone HD + mRNA-1345 Followed by Placebo | 0 | 947 | 0 |
| serious | COVID-19 | Infections and infestations | Fluzone HD + Placebo Followed by mRNA-1345 | 1 | 946 | 1 |
| serious | Cellulitis | Infections and infestations | Fluzone HD + mRNA-1345 Followed by Placebo | 1 | 947 | 1 |
| serious | Cellulitis | Infections and infestations | Fluzone HD + Placebo Followed by mRNA-1345 | 0 | 946 | 0 |
| serious | Gangrene | Infections and infestations | Fluzone HD + mRNA-1345 Followed by Placebo | 0 | 947 | 0 |
| serious | Gangrene | Infections and infestations | Fluzone HD + Placebo Followed by mRNA-1345 | 1 | 946 | 1 |
| serious | Gastrointestinal infection | Infections and infestations | Fluzone HD + mRNA-1345 Followed by Placebo | 0 | 947 | 0 |
| serious | Gastrointestinal infection | Infections and infestations | Fluzone HD + Placebo Followed by mRNA-1345 | 1 | 946 | 1 |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluzone HD + mRNA-1345 Followed by Placebo | 2 | 950 |
| Total, all-cause mortality | Fluzone HD + Placebo Followed by mRNA-1345 | 2 | 950 |
| Total, other adverse events | Fluzone HD + mRNA-1345 Followed by Placebo | 0 | 947 |
| Total, other adverse events | Fluzone HD + Placebo Followed by mRNA-1345 | 0 | 946 |
| Total, serious adverse events | Fluzone HD + mRNA-1345 Followed by Placebo | 23 | 947 |
| Total, serious adverse events | Fluzone HD + Placebo Followed by mRNA-1345 | 33 | 946 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42048601 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Fluzone HD + mRNA-1345 Followed by Placebo vs Fluzone HD + Placebo Followed by mRNA-1345: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection | Trial comparisons |
| Fluzone HD + mRNA-1345 Followed by Placebo vs Fluzone HD + Placebo Followed by mRNA-1345: Number of Participants With Unsolicited AEs Up to 21 Days After Day 22 Injection | Trial comparisons |
| Fluzone HD + mRNA-1345 Followed by Placebo vs Fluzone HD + Placebo Followed by mRNA-1345: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection | Trial comparisons |
| Fluzone HD + mRNA-1345 Followed by Placebo vs Fluzone HD + Placebo Followed by mRNA-1345: deaths from any cause | Trial comparisons |
| Fluzone HD + mRNA-1345 Followed by Placebo vs Fluzone HD + Placebo Followed by mRNA-1345: Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection | Trial comparisons |
| Fluzone HD + mRNA-1345 Followed by Placebo vs Fluzone HD + Placebo Followed by mRNA-1345: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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