Trial Outcomes & Findings for Study of a Quadrivalent High-Dose Influenza Vaccine and a Moderna COVID-19 Vaccine Administered Either Concomitantly or Singly in Participants 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine (NCT NCT04969276)

NCT ID: NCT04969276

Last Updated: 2025-09-12

Results Overview

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRF. Reported AEs for each arm were presented as pre-specified in the study protocol.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 306 participants
• Primary outcome timeframe: Within 30 minutes post vaccination
• Results posted on: 2025-09-12

Participant Flow

The study was conducted at 6 sites in the United States. A total of 306 participants were enrolled between 16 July 2021 to 05 August 2021.

A total of 296 participants were vaccinated in the study.

Participant milestones

Measure	Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine Participants received an injection of 0.7 milliliters (mL), fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, intramuscularly (IM) on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Study STARTED	100	101	105
Overall Study Safety Analysis Set (SafAS)	100	92	104
Overall Study COMPLETED	99	89	105
Overall Study NOT COMPLETED	1	12	0

Reasons for withdrawal

Measure	Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine Participants received an injection of 0.7 milliliters (mL), fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, intramuscularly (IM) on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Study Protocol Deviation	0	1	0
Overall Study Withdrawal by Subject	1	10	0
Overall Study Lost to Follow-up	0	1	0

Baseline Characteristics

Study of a Quadrivalent High-Dose Influenza Vaccine and a Moderna COVID-19 Vaccine Administered Either Concomitantly or Singly in Participants 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine

Baseline characteristics by cohort

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=100 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=101 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=105 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.	Total n=306 Participants Total of all reporting groups
Age, Continuous	71.3 years STANDARD_DEVIATION 4.76 • n=93 Participants	71.7 years STANDARD_DEVIATION 5.16 • n=4 Participants	72.0 years STANDARD_DEVIATION 4.89 • n=27 Participants	71.7 years STANDARD_DEVIATION 4.93 • n=483 Participants
Sex: Female, Male Female	55 Participants n=93 Participants	54 Participants n=4 Participants	63 Participants n=27 Participants	172 Participants n=483 Participants
Sex: Female, Male Male	45 Participants n=93 Participants	47 Participants n=4 Participants	42 Participants n=27 Participants	134 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	4 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants
Race (NIH/OMB) White	94 Participants n=93 Participants	95 Participants n=4 Participants	103 Participants n=27 Participants	292 Participants n=483 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants

PRIMARY outcome

Timeframe: Within 30 minutes post vaccination

Population: Analysis was performed on SafAS which included all participants who had received the study vaccine(s) and were analyzed according to the vaccine they actually received and study intervention group.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRF. Reported AEs for each arm were presented as pre-specified in the study protocol.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=100 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=92 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=104 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Number of Participants With Immediate Unsolicited Adverse Events (AEs)	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Within 7 days post-vaccination

Population: Analysis was performed on the SafAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

A solicited reaction (SR) was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited injection site reactions included injection site pain, axillary swelling and tenderness, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Reported AEs for each arm were presented as pre-specified in the study protocol.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=100 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=89 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=104 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Number of Participants With Solicited Injection Site Reactions Injection site pain	82 Participants	54 Participants	92 Participants
Number of Participants With Solicited Injection Site Reactions Axillary swelling	2 Participants	2 Participants	1 Participants
Number of Participants With Solicited Injection Site Reactions Axillary tenderness	3 Participants	3 Participants	3 Participants
Number of Participants With Solicited Injection Site Reactions Injection site erythema	22 Participants	10 Participants	32 Participants
Number of Participants With Solicited Injection Site Reactions Injection site swelling	15 Participants	6 Participants	27 Participants
Number of Participants With Solicited Injection Site Reactions Injection site induration	12 Participants	3 Participants	22 Participants
Number of Participants With Solicited Injection Site Reactions Injection site bruising	7 Participants	0 Participants	4 Participants

PRIMARY outcome

Timeframe: Within 7 days post-vaccination

Population: Analysis was performed on the SafAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

A SR was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia, shivering, fatigue, nausea and vomiting. Reported AEs for each arm were presented as pre-specified in the study protocol.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=100 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=89 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=104 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Number of Participants With Solicited Systemic Reactions Fever	12 Participants	1 Participants	12 Participants
Number of Participants With Solicited Systemic Reactions Headache	52 Participants	18 Participants	55 Participants
Number of Participants With Solicited Systemic Reactions Malaise	46 Participants	13 Participants	59 Participants
Number of Participants With Solicited Systemic Reactions Myalgia	50 Participants	20 Participants	64 Participants
Number of Participants With Solicited Systemic Reactions Arthralgia	24 Participants	8 Participants	27 Participants
Number of Participants With Solicited Systemic Reactions Shivering	32 Participants	6 Participants	22 Participants
Number of Participants With Solicited Systemic Reactions Fatigue	62 Participants	26 Participants	73 Participants
Number of Participants With Solicited Systemic Reactions Nausea	32 Participants	5 Participants	27 Participants
Number of Participants With Solicited Systemic Reactions Vomiting	4 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: Within 21 days post-vaccination

Population: Analysis was performed on the SafAS.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=100 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=92 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=104 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Number of Participants With Unsolicited Adverse Events	17 Participants	11 Participants	15 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 6 months post-vaccination

Population: Analysis was performed on the SafAS.

An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as one of scientific and medical concern specific to the sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Reported AEs for each arm were presented as pre-specified in the study protocol.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=100 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=92 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=104 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) SAEs	2 Participants	0 Participants	3 Participants
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) AESIs	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 6 months post-vaccination

Population: Analysis was performed on the SafAS population.

A MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department including medical advice seeking during the study visit or routine medical care. Reported AEs for each arm were presented as pre-specified in the study protocol.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=100 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=92 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=104 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Number of Participants With Medically Attended Adverse Events (MAAEs)	10 Participants	6 Participants	17 Participants

PRIMARY outcome

Timeframe: Day 1 (pre-vaccination)

Population: Analysis was performed on Immunogenicity analysis set which included all randomized participants who received at least 1 dose of the study vaccine and analyzed according to the vaccine they actually received and study intervention group. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

GMTs of anti-influenza and anti-COVID-19 antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=99 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=91 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=101 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 A/H1N1: Pre-vaccination	55.8 titers Interval 44.2 to 70.4	45.5 titers Interval 34.7 to 59.7	49.7 titers Interval 37.7 to 65.4
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 A/H3N2: Pre-vaccination	95.0 titers Interval 77.5 to 116.0	85.4 titers Interval 66.3 to 110.0	80.3 titers Interval 63.1 to 102.0
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 B/Yamagata: Pre-vaccination	221 titers Interval 178.0 to 274.0	204 titers Interval 159.0 to 262.0	203 titers Interval 163.0 to 252.0
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 B/Victoria: Pre-vaccination	163 titers Interval 137.0 to 194.0	155 titers Interval 127.0 to 190.0	165 titers Interval 136.0 to 201.0

PRIMARY outcome

Timeframe: Day 22 (post-vaccination)

Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=97 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=86 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=102 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 A/H1N1: Post-vaccination	363 titers Interval 276.0 to 476.0	366 titers Interval 272.0 to 491.0	41.2 titers Interval 31.4 to 54.2
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 A/H3N2: Post-vaccination	286 titers Interval 233.0 to 352.0	315 titers Interval 257.0 to 386.0	76.5 titers Interval 61.1 to 95.8
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 B/Yamagata: Post-vaccination	429 titers Interval 350.0 to 525.0	471 titers Interval 378.0 to 588.0	198 titers Interval 160.0 to 243.0
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 B/Victoria: Post-vaccination	377 titers Interval 325.0 to 438.0	390 titers Interval 327.0 to 465.0	176 titers Interval 146.0 to 212.0

PRIMARY outcome

Timeframe: Day 1 (pre-vaccination) and Day 22 (post-vaccination)

Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=96 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=86 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=100 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies A/H1N1	6.35 ratio Interval 4.88 to 8.26	8.10 ratio Interval 6.09 to 10.8	0.868 ratio Interval 0.821 to 0.917
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies A/H3N2	3.06 ratio Interval 2.54 to 3.7	3.54 ratio Interval 2.82 to 4.45	0.940 ratio Interval 0.87 to 1.01
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies B/Yamagata	1.94 ratio Interval 1.68 to 2.23	2.27 ratio Interval 1.84 to 2.79	0.983 ratio Interval 0.918 to 1.05
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies B/Victoria	2.27 ratio Interval 1.96 to 2.63	2.44 ratio Interval 2.01 to 2.96	1.05 ratio Interval 0.972 to 1.14

PRIMARY outcome

Timeframe: Day 1 (pre-vaccination)

Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=10 (1/dilution) are reported in the outcome measure.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=99 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=91 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=101 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) A/H1N1: Pre-vaccination	97.0 percentage of participants Interval 91.4 to 99.4	94.5 percentage of participants Interval 87.6 to 98.2	91.1 percentage of participants Interval 83.8 to 95.8
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) A/H3N2: Pre-vaccination	100 percentage of participants Interval 96.3 to 100.0	98.9 percentage of participants Interval 94.0 to 100.0	99.0 percentage of participants Interval 94.6 to 100.0
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) B/Yamagata: Pre-vaccination	100 percentage of participants Interval 96.3 to 100.0	100 percentage of participants Interval 96.0 to 100.0	99.0 percentage of participants Interval 94.6 to 100.0
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) B/Victoria: Pre-vaccination	100 percentage of participants Interval 96.3 to 100.0	100 percentage of participants Interval 96.0 to 100.0	100 percentage of participants Interval 96.4 to 100.0

PRIMARY outcome

Timeframe: Day 22 (post-vaccination)

Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=10 (1/dilution) are reported in the outcome measure.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=97 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=86 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=102 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) A/H1N1: Post-vaccination	100 percentage of participants Interval 96.3 to 100.0	100 percentage of participants Interval 95.8 to 100.0	91.2 percentage of participants Interval 83.9 to 95.9
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) A/H3N2: Post-vaccination	100 percentage of participants Interval 96.3 to 100.0	100 percentage of participants Interval 95.8 to 100.0	99.0 percentage of participants Interval 94.7 to 100.0
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) B/Yamagata: Post-vaccination	100 percentage of participants Interval 96.3 to 100.0	100 percentage of participants Interval 95.8 to 100.0	99.0 percentage of participants Interval 94.7 to 100.0
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) B/Victoria: Post-vaccination	100 percentage of participants Interval 96.3 to 100.0	100 percentage of participants Interval 95.8 to 100.0	100 percentage of participants Interval 96.4 to 100.0

PRIMARY outcome

Timeframe: Day 22 (post-vaccination)

Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

Anti-influenza and anti-COVID-19 antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (<)10 (1/dilution) and a post-vaccination titer >=40 (1/dilution) or a pre-vaccination titer >=10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 22.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=96 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=86 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=100 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens A/H1N1	68.8 percentage of participants Interval 58.5 to 77.8	72.1 percentage of participants Interval 61.4 to 81.2	0.0 percentage of participants Interval 0.0 to 3.6
Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens A/H3N2	43.8 percentage of participants Interval 33.6 to 54.3	47.7 percentage of participants Interval 36.8 to 58.7	0.0 percentage of participants Interval 0.0 to 3.6
Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens B/Yamagata	17.7 percentage of participants Interval 10.7 to 26.8	20.9 percentage of participants Interval 12.9 to 31.0	1.0 percentage of participants Interval 0.0 to 5.4
Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens B/Victoria	30.2 percentage of participants Interval 21.3 to 40.4	24.4 percentage of participants Interval 15.8 to 34.9	1.0 percentage of participants Interval 0.0 to 5.4

PRIMARY outcome

Timeframe: Day 1 (pre-vaccination)

Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=40 (1/dilution) are reported in the outcome measure.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=99 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=91 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=101 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Percentage of Participants With Antibody Titers >=40 (1/Dilution) A/H1N1: Pre-vaccination	65.7 percentage of participants Interval 55.4 to 74.9	56.0 percentage of participants Interval 45.2 to 66.4	59.4 percentage of participants Interval 49.2 to 69.1
Percentage of Participants With Antibody Titers >=40 (1/Dilution) A/H3N2: Pre-vaccination	83.8 percentage of participants Interval 75.1 to 90.5	79.1 percentage of participants Interval 69.3 to 86.9	77.2 percentage of participants Interval 67.8 to 85.0
Percentage of Participants With Antibody Titers >=40 (1/Dilution) B/Yamagata: Pre-vaccination	97.0 percentage of participants Interval 91.4 to 99.4	90.1 percentage of participants Interval 82.1 to 95.4	96.0 percentage of participants Interval 90.2 to 98.9
Percentage of Participants With Antibody Titers >=40 (1/Dilution) B/Victoria: Pre-vaccination	99.0 percentage of participants Interval 94.5 to 100.0	94.5 percentage of participants Interval 87.6 to 98.2	95.0 percentage of participants Interval 88.8 to 98.4

PRIMARY outcome

Timeframe: Day 22 (post-vaccination)

Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=40 (1/dilution) are reported in the outcome measure.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=97 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=86 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=102 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Percentage of Participants With Antibody Titers >=40 (1/Dilution) A/H1N1: Post-vaccination	94.8 percentage of participants Interval 88.4 to 98.3	95.3 percentage of participants Interval 88.5 to 98.7	53.9 percentage of participants Interval 43.8 to 63.8
Percentage of Participants With Antibody Titers >=40 (1/Dilution) A/H3N2: Post-vaccination	96.9 percentage of participants Interval 91.2 to 99.4	100 percentage of participants Interval 95.8 to 100.0	72.5 percentage of participants Interval 62.8 to 80.9
Percentage of Participants With Antibody Titers >=40 (1/Dilution) B/Yamagata: Post-vaccination	100 percentage of participants Interval 96.3 to 100.0	98.8 percentage of participants Interval 93.7 to 100.0	96.1 percentage of participants Interval 90.3 to 98.9
Percentage of Participants With Antibody Titers >=40 (1/Dilution) B/Victoria: Post-vaccination	100 percentage of participants Interval 96.3 to 100.0	100 percentage of participants Interval 95.8 to 100.0	96.1 percentage of participants Interval 90.3 to 98.9

PRIMARY outcome

Timeframe: Day 1 (pre-vaccination)

Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

GMCs of Anti-S binding IgG antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) method and were measured in binding antibody units/milliliter (BAU/mL).

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=99 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=91 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=102 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies	565 BAU/mL Interval 479.0 to 666.0	462 BAU/mL Interval 382.0 to 560.0	552 BAU/mL Interval 461.0 to 662.0

PRIMARY outcome

Timeframe: Day 22 (post-vaccination)

Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

GMCs of Anti-S binding IgG antibodies were assessed using ELISA method and were measured in BAU/mL.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=97 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=86 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=103 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies	7634 BAU/mL Interval 6445.0 to 9042.0	395 BAU/mL Interval 311.0 to 502.0	7904 BAU/mL Interval 6883.0 to 9077.0

PRIMARY outcome

Timeframe: Day 1 (pre-vaccination) and Day 22 (post-vaccination)

Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

GMCs of Anti-S binding IgG antibodies were assessed using ELISA method. GMCR was calculated as the ratio of GMC post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=96 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=86 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=102 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Geometric Mean Concentration Ratio (GMCR) of Anti-S Binding IgG Antibodies	13.7 ratio Interval 11.2 to 16.8	0.875 ratio Interval 0.745 to 1.03	14.2 ratio Interval 12.0 to 16.9

PRIMARY outcome

Timeframe: Day 22 (post-vaccination)

Population: Analysis was performed on immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

Percentage of participants with >=2-fold and >=4-fold rise in Anti-S binding IgG antibodies at Day 22 (post-vaccination) are reported in this outcome measure. Percentage of participants with >=2-fold rise are those for whom the computed value at Day 22 was *2 compared to the computed value at Day 1 and percentage of participants with >=4-fold rise are those for whom the computed value at Day 22 was *4 compared to the computed value at Day 1.

Outcome measures

Measure	Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=96 Participants Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=86 Participants Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.	Group 3: COVID-19 Vaccine n=102 Participants Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies >= 2-fold rise	97.9 percentage of participants Interval 92.7 to 99.7	3.5 percentage of participants Interval 0.7 to 9.9	98.0 percentage of participants Interval 93.1 to 99.8
Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies >= 4-fold rise	92.7 percentage of participants Interval 85.6 to 97.0	2.3 percentage of participants Interval 0.3 to 8.1	95.1 percentage of participants Interval 88.9 to 98.4

Adverse Events

Group 3: COVID-19 Vaccine

Serious events: 3 serious events

Other events: 100 other events

Deaths: 0 deaths

Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine

Serious events: 2 serious events

Other events: 94 other events

Deaths: 0 deaths

Group 2: Fluzone HD Quadrivalent Influenza Vaccine

Serious events: 0 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 3: COVID-19 Vaccine n=104 participants at risk Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.	Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=100 participants at risk Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=92 participants at risk Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Cardiac disorders Myocardial Infarction	0.00% 0/104 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	1.0% 1/100 • Number of events 1 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	0.00% 0/92 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
Endocrine disorders Thyroid Mass	0.96% 1/104 • Number of events 1 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	0.00% 0/100 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	0.00% 0/92 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
Gastrointestinal disorders Diabetic Gastroparesis	0.96% 1/104 • Number of events 1 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	0.00% 0/100 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	0.00% 0/92 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
Injury, poisoning and procedural complications Pelvic Fracture	0.96% 1/104 • Number of events 1 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	0.00% 0/100 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	0.00% 0/92 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
Musculoskeletal and connective tissue disorders Exostosis	0.96% 1/104 • Number of events 1 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	0.00% 0/100 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	0.00% 0/92 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Thyroid Cancer	0.00% 0/104 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	1.0% 1/100 • Number of events 1 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	0.00% 0/92 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.

Other adverse events

Measure	Group 3: COVID-19 Vaccine n=104 participants at risk Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.	Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine n=100 participants at risk Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.	Group 2: Fluzone HD Quadrivalent Influenza Vaccine n=92 participants at risk Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Gastrointestinal disorders Nausea	26.0% 27/104 • Number of events 27 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	32.0% 32/100 • Number of events 32 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	6.5% 6/92 • Number of events 6 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
General disorders Chills	21.2% 22/104 • Number of events 22 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	32.0% 32/100 • Number of events 32 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	6.5% 6/92 • Number of events 6 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
General disorders Fatigue	70.2% 73/104 • Number of events 73 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	62.0% 62/100 • Number of events 62 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	28.3% 26/92 • Number of events 26 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
General disorders Injection Site Bruising	3.8% 4/104 • Number of events 4 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	7.0% 7/100 • Number of events 8 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	0.00% 0/92 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
General disorders Injection Site Erythema	30.8% 32/104 • Number of events 32 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	22.0% 22/100 • Number of events 28 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	10.9% 10/92 • Number of events 10 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
General disorders Injection Site Induration	21.2% 22/104 • Number of events 22 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	12.0% 12/100 • Number of events 12 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	3.3% 3/92 • Number of events 3 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
General disorders Injection Site Pain	88.5% 92/104 • Number of events 92 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	82.0% 82/100 • Number of events 139 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	58.7% 54/92 • Number of events 54 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
General disorders Injection Site Swelling	26.0% 27/104 • Number of events 27 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	15.0% 15/100 • Number of events 17 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	6.5% 6/92 • Number of events 6 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
General disorders Malaise	56.7% 59/104 • Number of events 59 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	46.0% 46/100 • Number of events 46 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	14.1% 13/92 • Number of events 13 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
General disorders Pyrexia	12.5% 13/104 • Number of events 13 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	12.0% 12/100 • Number of events 12 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	1.1% 1/92 • Number of events 1 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
Musculoskeletal and connective tissue disorders Arthralgia	26.0% 27/104 • Number of events 28 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	24.0% 24/100 • Number of events 24 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	8.7% 8/92 • Number of events 8 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
Musculoskeletal and connective tissue disorders Myalgia	61.5% 64/104 • Number of events 64 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	50.0% 50/100 • Number of events 50 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	21.7% 20/92 • Number of events 20 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
Nervous system disorders Headache	52.9% 55/104 • Number of events 55 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	52.0% 52/100 • Number of events 52 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.	19.6% 18/92 • Number of events 18 • Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination SR: "expected" adverse reaction (sign/symptom) observed \& reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF \& considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis \& onset window post-vaccination. SafAS. In AE section, SR Fever \& shivering are reported as Pyrexia \& chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.

Additional Information

Trial Transparency Team

Sanofi Pasteur

Phone: 800-633-1610

Email: Contact-US@sanofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
• Publication restrictions are in place

Restriction type: OTHER