Trial Outcomes & Findings for 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 NCT06060457)
NCT ID: NCT06060457
Last Updated: 2025-07-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1900 participants
Primary outcome timeframe
Within 7 days after Day 1 injection
Results posted on
2025-07-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
950
|
950
|
|
Overall Study
Received Day 1 Injection
|
946
|
947
|
|
Overall Study
Received Day 22 Injection
|
919
|
911
|
|
Overall Study
Safety Set
|
947
|
946
|
|
Overall Study
COMPLETED
|
914
|
909
|
|
Overall Study
NOT COMPLETED
|
36
|
41
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
17
|
19
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Serious Adverse Reaction (SAR)/Reactogenicity Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
15
|
|
Overall Study
Other Than Specified
|
2
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=950 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=950 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
Total
n=1900 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.7 years
STANDARD_DEVIATION 4.80 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 4.80 • n=7 Participants
|
70.7 years
STANDARD_DEVIATION 4.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
548 Participants
n=5 Participants
|
530 Participants
n=7 Participants
|
1078 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
402 Participants
n=5 Participants
|
420 Participants
n=7 Participants
|
822 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
209 Participants
n=5 Participants
|
222 Participants
n=7 Participants
|
431 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
728 Participants
n=5 Participants
|
722 Participants
n=7 Participants
|
1450 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
187 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
378 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
735 Participants
n=5 Participants
|
738 Participants
n=7 Participants
|
1473 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after Day 1 injectionPopulation: 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.
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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=947 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=945 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
|
689 Participants
|
547 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after Day 22 injectionPopulation: 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.
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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=919 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=910 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection
|
251 Participants
|
557 Participants
|
PRIMARY outcome
Timeframe: Up to 21 days after Day 1 injectionPopulation: 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.
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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=947 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=946 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection
|
72 Participants
|
72 Participants
|
PRIMARY outcome
Timeframe: Up to 21 days after Day 22 injectionPopulation: 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.
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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=947 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=946 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
Number of Participants With Unsolicited AEs Up to 21 Days After Day 22 Injection
|
60 Participants
|
71 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 202Population: 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.
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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=947 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=946 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
MAAEs
|
194 Participants
|
191 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
AESIs
|
0 Participants
|
1 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
SAEs
|
23 Participants
|
33 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
AEs Leading to Discontinuation
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 22 (for Arm 1) and Day 43 (for Arm 2)Population: 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.
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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=897 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=858 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (nAbs)
RSV-A
|
11800.26 IU/mL
Interval 11063.69 to 12585.87
|
18874.12 IU/mL
Interval 17670.37 to 20159.87
|
|
Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (nAbs)
RSV-B
|
4197.74 IU/mL
Interval 3949.53 to 4461.54
|
6579.15 IU/mL
Interval 6178.21 to 7006.11
|
PRIMARY outcome
Timeframe: Day 22Population: 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.
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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=894 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=880 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza A H1N1 Antibody
|
108.11 titer
Interval 99.76 to 117.15
|
124.15 titer
Interval 114.49 to 134.62
|
|
GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza A H3N2 Antibody
|
198.53 titer
Interval 183.61 to 214.67
|
228.83 titer
Interval 211.5 to 247.58
|
|
GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza B Austria Antibody
|
105.32 titer
Interval 98.34 to 112.8
|
118.27 titer
Interval 110.37 to 126.74
|
|
GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza B Phuket Antibody
|
33.17 titer
Interval 31.28 to 35.17
|
34.97 titer
Interval 32.97 to 37.1
|
SECONDARY outcome
Timeframe: Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2)Population: 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.
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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=897 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=858 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
Percentage of Participants With Seroresponse for RSV-A and RSV-B nAbs, as Measured by HAI Assay
RSV-A
|
64.7 percentage of participants
Interval 61.4 to 67.8
|
78.2 percentage of participants
Interval 75.3 to 80.9
|
|
Percentage of Participants With Seroresponse for RSV-A and RSV-B nAbs, as Measured by HAI Assay
RSV-B
|
48.7 percentage of participants
Interval 45.3 to 52.0
|
61.9 percentage of participants
Interval 58.5 to 65.2
|
SECONDARY outcome
Timeframe: Day 22 (for Arm 1) or Day 43 (for Arm 2)Population: 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.
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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=897 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=858 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
Geometric Mean Fold-Rise (GMFR) of Postinjection RSV-A and RSV-B nAbs Antibodies for Influenza, as Measured by HAI Assay
RSV-A
|
6.49 ratio
Interval 6.03 to 6.99
|
10.00 ratio
Interval 9.25 to 10.82
|
|
Geometric Mean Fold-Rise (GMFR) of Postinjection RSV-A and RSV-B nAbs Antibodies for Influenza, as Measured by HAI Assay
RSV-B
|
4.08 ratio
Interval 3.81 to 4.36
|
5.92 ratio
Interval 5.48 to 6.39
|
SECONDARY outcome
Timeframe: Day 22 (Arm 1) or Day 43 (Arm 2)Population: 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.
≥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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=897 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=858 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
Percentage of Participants With ≥2-fold Increase in RSV-A and RSV-B nAbs
RSV-A
|
85.4 percentage of participants
Interval 82.9 to 87.6
|
93.2 percentage of participants
Interval 91.3 to 94.8
|
|
Percentage of Participants With ≥2-fold Increase in RSV-A and RSV-B nAbs
RSV-B
|
75.4 percentage of participants
Interval 72.5 to 78.2
|
83.5 percentage of participants
Interval 80.8 to 85.9
|
SECONDARY outcome
Timeframe: Day 22Population: 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.
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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=894 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=880 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A H1N1 Antibody
|
56.0 percentage of participants
Interval 52.7 to 59.3
|
59.0 percentage of participants
Interval 55.6 to 62.2
|
|
Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A H3N2 Antibody
|
60.3 percentage of participants
Interval 57.0 to 63.5
|
65.8 percentage of participants
Interval 62.6 to 68.9
|
|
Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza B Austria Antibody
|
55.5 percentage of participants
Interval 52.2 to 58.8
|
59.1 percentage of participants
Interval 55.8 to 62.4
|
|
Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza B Phuket Antibody
|
31.7 percentage of participants
Interval 28.6 to 34.8
|
32.8 percentage of participants
Interval 29.7 to 36.1
|
SECONDARY outcome
Timeframe: Day 22Population: 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.
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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=894 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=880 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
GMFR of Serum Ab Level, as Measured by HAI Assay
Influenza B Phuket Antibody
|
2.73 ratio
Interval 2.56 to 2.9
|
2.88 ratio
Interval 2.7 to 3.07
|
|
GMFR of Serum Ab Level, as Measured by HAI Assay
Influenza A H1N1 Antibody
|
5.21 ratio
Interval 4.76 to 5.71
|
5.78 ratio
Interval 5.25 to 6.36
|
|
GMFR of Serum Ab Level, as Measured by HAI Assay
Influenza A H3N2 Antibody
|
6.20 ratio
Interval 5.64 to 6.82
|
7.16 ratio
Interval 6.49 to 7.89
|
|
GMFR of Serum Ab Level, as Measured by HAI Assay
Influenza B Austria Antibody
|
4.87 ratio
Interval 4.48 to 5.3
|
5.64 ratio
Interval 5.17 to 6.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 through Day 202Population: 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.
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.
Outcome measures
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=947 Participants
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=946 Participants
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
Number of Deaths Related to Study Drug
Deaths
|
2 Participants
|
2 Participants
|
|
Number of Deaths Related to Study Drug
Deaths related to study drug
|
0 Participants
|
0 Participants
|
Adverse Events
Fluzone HD + mRNA-1345 Followed by Placebo
Serious events: 23 serious events
Other events: 0 other events
Deaths: 2 deaths
Fluzone HD + Placebo Followed by mRNA-1345
Serious events: 33 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Fluzone HD + mRNA-1345 Followed by Placebo
n=947 participants at risk
Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.
|
Fluzone HD + Placebo Followed by mRNA-1345
n=946 participants at risk
Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
|
|---|---|---|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Infections and infestations
COVID-19
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Infections and infestations
Cellulitis
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Infections and infestations
Gangrene
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Infections and infestations
Influenza
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Infections and infestations
Pneumonia
|
0.21%
2/947 • Number of events 2 • 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".
|
0.32%
3/946 • Number of events 3 • 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".
|
|
Infections and infestations
Pneumonia aspiration
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Infections and infestations
Sepsis
|
0.11%
1/947 • Number of events 1 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Infections and infestations
Septic encephalopathy
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Infections and infestations
Septic shock
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia stage 1
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
1/947 • Number of events 1 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Cardiac disorders
Angina pectoris
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/947 • 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".
|
0.21%
2/946 • Number of events 2 • 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".
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Cardiac disorders
Atrial fibrillation
|
0.21%
2/947 • Number of events 2 • 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".
|
0.21%
2/946 • Number of events 2 • 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".
|
|
Cardiac disorders
Bradycardia
|
0.21%
2/947 • Number of events 2 • 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".
|
0.00%
0/946 • 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".
|
|
Cardiac disorders
Cardiac arrest
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/947 • 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".
|
0.21%
2/946 • Number of events 2 • 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".
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Cardiac disorders
Pericardial effusion
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Vascular disorders
Deep vein thrombosis
|
0.11%
1/947 • Number of events 1 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Vascular disorders
Hypertension
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Vascular disorders
Hypotension
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.21%
2/947 • Number of events 2 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.21%
2/947 • Number of events 3 • 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".
|
0.00%
0/946 • 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".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.21%
2/947 • Number of events 2 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Gastrointestinal disorders
Colitis
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
General disorders
Death
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
General disorders
Oedema peripheral
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Investigations
Fibrin D dimer increased
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Investigations
Troponin increased
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Injury, poisoning and procedural complications
Central cord syndrome
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Injury, poisoning and procedural complications
Fall
|
0.11%
1/947 • Number of events 1 • 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".
|
0.00%
0/946 • 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".
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.11%
1/947 • Number of events 1 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.11%
1/947 • Number of events 1 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
|
Product Issues
Device dislocation
|
0.00%
0/947 • 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".
|
0.11%
1/946 • Number of events 1 • 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".
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place