Trial Outcomes & Findings for Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults (NCT NCT04576702)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

471 participants

Primary outcome timeframe

28 days post-vaccination

Results posted on

2024-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational aIIV4c Group aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Overall Study STARTED	116	119	116	120
Overall Study COMPLETED	112	114	112	116
Overall Study NOT COMPLETED	4	5	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigational aIIV4c Group aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Overall Study Death	1	0	0	0
Overall Study Withdrawal by Subject	0	2	1	0
Overall Study Lost to Follow-up	3	3	3	4

Baseline Characteristics

Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational aIIV4c Group n=116 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=119 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=116 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=120 Participants RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Total n=471 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants	57 Participants n=7 Participants	56 Participants n=5 Participants	58 Participants n=4 Participants	227 Participants n=21 Participants
Age, Categorical >=65 years	60 Participants n=5 Participants	62 Participants n=7 Participants	60 Participants n=5 Participants	62 Participants n=4 Participants	244 Participants n=21 Participants
Age, Continuous	65.0 years STANDARD_DEVIATION 9.18 • n=5 Participants	64.7 years STANDARD_DEVIATION 8.49 • n=7 Participants	65.0 years STANDARD_DEVIATION 7.49 • n=5 Participants	65.4 years STANDARD_DEVIATION 9.02 • n=4 Participants	65.0 years STANDARD_DEVIATION 8.55 • n=21 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	72 Participants n=7 Participants	71 Participants n=5 Participants	71 Participants n=4 Participants	283 Participants n=21 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	47 Participants n=7 Participants	45 Participants n=5 Participants	49 Participants n=4 Participants	188 Participants n=21 Participants
Race/Ethnicity, Customized White	89 Participants n=5 Participants	100 Participants n=7 Participants	99 Participants n=5 Participants	105 Participants n=4 Participants	393 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	23 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	15 Participants n=4 Participants	67 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment United States	116 Participants n=5 Participants	119 Participants n=7 Participants	116 Participants n=5 Participants	120 Participants n=4 Participants	471 Participants n=21 Participants
vaccinated within 3 previous influenza seasons yes	84 Participants n=5 Participants	85 Participants n=7 Participants	84 Participants n=5 Participants	85 Participants n=4 Participants	338 Participants n=21 Participants
vaccinated within 3 previous influenza seasons no	32 Participants n=5 Participants	34 Participants n=7 Participants	32 Participants n=5 Participants	35 Participants n=4 Participants	133 Participants n=21 Participants

PRIMARY outcome

Timeframe: 28 days post-vaccination

Population: Per Protocol Set (PPS): All subjects in the Full Analysis Set (FAS) Immunogenicity who: * Correctly received the vaccine (ie, received the vaccine to which the subject was randomized). * Had no clinical study report (CSR)-reportable protocol deviation (PD) leading to exclusion (ie, impacting the results) as defined prior to unblinding. * Had immunogenicity assessments within the window of +/- 7 days around the Day 29 visit, and Day 1 sample taken within 3 days before vaccination.

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=110 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=114 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=109 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=116 Participants RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses A/H1N1 Day 1 HI GMT	19.5 titer Interval 15.5 to 24.5	17.04 titer Interval 13.6 to 21.3	21.85 titer Interval 17.4 to 27.5	18.05 titer Interval 14.5 to 22.5
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses A/H1N1 Day 29 HI GMT	146.05 titer Interval 116.1 to 183.7	111.38 titer Interval 88.8 to 139.7	119.54 titer Interval 95.0 to 150.5	173.08 titer Interval 138.5 to 216.4
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses B/Yamagata Day 1 HI GMT	16.95 titer Interval 14.3 to 20.1	16.02 titer Interval 13.5 to 19.0	14.59 titer Interval 12.3 to 17.3	15.99 titer Interval 13.5 to 18.9
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses B/Yamagata Day 29 HI GMT	69.35 titer Interval 58.7 to 81.9	50.99 titer Interval 43.3 to 60.1	37.51 titer Interval 31.7 to 44.4	60.25 titer Interval 51.2 to 70.8
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses B/Victoria Day 1 HI GMT	21.86 titer Interval 18.5 to 25.8	22.02 titer Interval 18.7 to 25.9	20.42 titer Interval 17.3 to 24.2	24.82 titer Interval 21.1 to 29.2
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses B/Victoria Day 29 HI GMT	94.82 titer Interval 80.4 to 111.8	69.49 titer Interval 59.1 to 81.7	52.35 titer Interval 44.3 to 61.8	75.50 titer Interval 64.3 to 88.6
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses A/H3N2 Day 1 MN GMT	71.44 titer Interval 61.7 to 82.7	59.37 titer Interval 51.4 to 68.6	60.20 titer Interval 52.0 to 69.7	64.93 titer Interval 56.3 to 74.9
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses A/H3N2 Day 29 MN GMT	138.88 titer Interval 120.7 to 159.8	117.28 titer Interval 102.2 to 134.6	106.22 titer Interval 92.3 to 122.3	174.78 titer Interval 152.6 to 200.2

PRIMARY outcome

Timeframe: 28 days post-vaccination

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=114 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=109 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=116 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses A/H3N2 MN GMR (aIIV4c/comparator group)	1.18 Ratio Interval 0.98 to 1.43	1.31 Ratio Interval 1.08 to 1.59	0.79 Ratio Interval 0.66 to 0.96	—
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses A/H1N1 HI GMR (aIIV4c/comparator group)	1.31 Ratio Interval 0.96 to 1.79	1.22 Ratio Interval 0.89 to 1.68	0.84 Ratio Interval 0.62 to 1.15	—
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses B/Yamagata HI GMR (aIIV4c/comparator group)	1.36 Ratio Interval 1.08 to 1.71	1.85 Ratio Interval 1.47 to 2.33	1.15 Ratio Interval 0.92 to 1.44	—
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses B/Victoria HI GMR (aIIV4c/comparator group)	1.36 Ratio Interval 1.09 to 1.71	1.81 Ratio Interval 1.44 to 2.27	1.26 Ratio Interval 1.0 to 1.57	—

PRIMARY outcome

Timeframe: 28 days post-vaccination

Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=110 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=114 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=109 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=116 Participants RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses A/H1N1 HI seroconversion Day 29	61.8 percentage of subjects Interval 52.1 to 70.9	54.4 percentage of subjects Interval 44.8 to 63.7	50.5 percentage of subjects Interval 40.7 to 60.2	61.2 percentage of subjects Interval 51.7 to 70.1
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses B/Yamagata HI seroconversion Day 29	42.7 percentage of subjects Interval 33.3 to 52.5	31.6 percentage of subjects Interval 23.2 to 40.9	19.3 percentage of subjects Interval 12.3 to 27.9	37.9 percentage of subjects Interval 29.1 to 47.4
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses B/Victoria HI seroconversion Day 29	46.4 percentage of subjects Interval 36.8 to 56.1	33.3 percentage of subjects Interval 24.8 to 42.8	26.6 percentage of subjects Interval 18.6 to 35.9	40.5 percentage of subjects Interval 31.5 to 50.0
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses A/H3N2 MN seroconversion Day 29	21.8 percentage of subjects Interval 14.5 to 30.7	20.2 percentage of subjects Interval 13.2 to 28.7	9.2 percentage of subjects Interval 4.5 to 16.2	32.8 percentage of subjects Interval 24.3 to 42.1

PRIMARY outcome

Timeframe: 28 days post-vaccination

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=110 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=114 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=109 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=116 Participants RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses A/H1N1 Day 1	44.5 percentage of subjects Interval 35.1 to 54.3	36.8 percentage of subjects Interval 28.0 to 46.4	41.3 percentage of subjects Interval 31.9 to 51.1	38.8 percentage of subjects Interval 29.9 to 48.3
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses A/H1N1 Day 29	85.5 percentage of subjects Interval 77.5 to 91.5	81.6 percentage of subjects Interval 73.2 to 88.2	82.6 percentage of subjects Interval 74.1 to 89.2	84.5 percentage of subjects Interval 76.6 to 90.5
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses B/Yamagata day 1	27.3 percentage of subjects Interval 19.2 to 36.6	23.7 percentage of subjects Interval 16.2 to 32.6	20.2 percentage of subjects Interval 13.1 to 28.9	28.4 percentage of subjects Interval 20.5 to 37.6
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses B/Yamagata Day 29	81.8 percentage of subjects Interval 73.3 to 88.5	64.0 percentage of subjects Interval 54.5 to 72.8	52.3 percentage of subjects Interval 42.5 to 61.9	65.5 percentage of subjects Interval 56.1 to 74.1
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses B/Victoria Day 1	32.7 percentage of subjects Interval 24.1 to 42.3	32.5 percentage of subjects Interval 24.0 to 41.9	30.3 percentage of subjects Interval 21.8 to 39.8	38.8 percentage of subjects Interval 29.9 to 48.3
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses B/Victoria Day 29	90.0 percentage of subjects Interval 82.8 to 94.9	72.8 percentage of subjects Interval 63.7 to 80.7	69.7 percentage of subjects Interval 60.9 to 78.2	79.3 percentage of subjects Interval 70.8 to 86.3

SECONDARY outcome

Timeframe: 7 days post-vaccination

Population: Solicited Safety Set, defined as all subjects in the FAS with any solicited AE data.

The percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination.

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=115 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=117 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=114 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=119 Participants RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions Solicited local AEs	70 Participants	52 Participants	67 Participants	51 Participants
Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions Solicited systemic AEs	69 Participants	51 Participants	57 Participants	64 Participants
Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions solicited AEs	85 Participants	72 Participants	83 Participants	80 Participants
Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions analgesic/antipyretic use	18 Participants	9 Participants	11 Participants	9 Participants

SECONDARY outcome

Timeframe: 28 days post-vaccination

Population: Unsolicited Safety Set, defined as all subjects in the FAS with any unsolicited AE data

The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29. Related AEs = considered at least possibly related to study vaccination by the investigator.

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=116 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=119 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=116 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=120 Participants RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events Any Unsolicited AE	23 Participants	27 Participants	23 Participants	29 Participants
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events Any Related Unsolicited AE	1 Participants	1 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 180 days post-vaccination

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=116 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=119 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=116 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=120 Participants RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period Any Serious Unsolicited AE	2 Participants	1 Participants	4 Participants	6 Participants
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period Any Related Serious Unsolicited AE	0 Participants	0 Participants	0 Participants	0 Participants
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period Any Unsolicited AE of Special Interest	1 Participants	0 Participants	0 Participants	0 Participants
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period Any Medically Attended AE	21 Participants	13 Participants	15 Participants	21 Participants
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period Any Unsolicited AE Leading to Withdrawal from the Study	1 Participants	0 Participants	0 Participants	0 Participants
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period Any Death	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days post-vaccination

Population: Per Protocol Set (PPS): All subjects in the FAS Immunogenicity who: * Correctly received the vaccine (ie, received the vaccine to which the subject was randomized). * Had no CSR-reportable PD leading to exclusion (ie, impacting the results) as defined prior to unblinding. * Had immunogenicity assessments within the window of +/- 7 days around the Day 29 visit, and Day 1 sample taken within 3 days before vaccination.

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=110 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=114 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=109 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=116 Participants RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses A/H1N1 Day 29	1261.77 titer Interval 997.2 to 1596.5	1036.72 titer Interval 820.3 to 1310.3	1050.54 titer Interval 829.5 to 1330.4	1719.68 titer Interval 1368.0 to 2161.7
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses B/Yamagata Day 1	19.48 titer Interval 17.0 to 22.3	15.55 titer Interval 13.6 to 17.8	17.50 titer Interval 15.2 to 20.1	17.62 titer Interval 15.4 to 20.1
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses A/H1N1 Day 1	158.64 titer Interval 122.0 to 206.3	102.88 titer Interval 79.5 to 133.1	162.19 titer Interval 124.6 to 211.1	138.73 titer Interval 107.5 to 179.0
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses B/Yamagata Day 29	48.08 titer Interval 41.9 to 55.2	42.89 titer Interval 37.4 to 49.1	39.01 titer Interval 34.0 to 44.8	56.12 titer Interval 49.1 to 64.1
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses B/Victoria Day 1	18.63 titer Interval 16.1 to 21.6	15.71 titer Interval 13.6 to 18.1	18.02 titer Interval 15.6 to 20.9	18.02 titer Interval 15.7 to 20.8
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses B/Victoria Day 29	58.47 titer Interval 50.4 to 67.8	47.63 titer Interval 41.1 to 55.2	44.88 titer Interval 38.7 to 52.1	61.8 titer Interval 53.5 to 71.4

SECONDARY outcome

Timeframe: 28 days post-vaccination

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=114 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=109 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=116 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses A/H1N1 Day 29 MN GMR (aIIV4c/comparator group)	1.22 ratio Interval 0.88 to 1.68	1.20 ratio Interval 0.87 to 1.66	0.73 ratio Interval 0.53 to 1.01	—
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses B/Yamagata Day 29 MN GMR (aIIV4c/comparator group)	1.12 ratio Interval 0.93 to 1.35	1.23 ratio Interval 1.02 to 1.49	0.86 ratio Interval 0.71 to 1.03	—
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses B/Victoria Day 29 MN GMR (aIIV4c/comparator group)	1.23 ratio Interval 1.0 to 1.5	1.30 ratio Interval 1.06 to 1.6	0.95 ratio Interval 0.77 to 1.16	—

SECONDARY outcome

Timeframe: 28 days post-vaccination

Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=110 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=114 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=109 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=116 Participants RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses A/H1N1 Day 29	61.8 percentage of subjects Interval 52.1 to 70.9	60.5 percentage of subjects Interval 50.9 to 69.6	53.2 percentage of subjects Interval 43.4 to 62.8	70.7 percentage of subjects Interval 61.5 to 78.8
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses B/Yamagata Day 29	22.7 percentage of subjects Interval 15.3 to 31.7	28.1 percentage of subjects Interval 20.1 to 37.3	15.6 percentage of subjects Interval 9.4 to 23.8	33.6 percentage of subjects Interval 25.1 to 43.0
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses B/Victoria Day 29	29.1 percentage of subjects Interval 20.8 to 38.5	26.3 percentage of subjects Interval 18.5 to 35.4	22.0 percentage of subjects Interval 14.6 to 31.0	37.1 percentage of subjects Interval 28.3 to 46.5

SECONDARY outcome

Timeframe: 180 days post-vaccination

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=108 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=110 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=110 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=113 Participants RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses A/H1N1 Day 181	156.47 titer Interval 127.6 to 191.9	144.08 titer Interval 117.6 to 176.5	157.72 titer Interval 128.9 to 193.0	198.17 titer Interval 162.3 to 242.0
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses B/Yamagata Day 181	34.70 titer Interval 29.2 to 41.3	33.26 titer Interval 28.0 to 39.5	23.56 titer Interval 19.8 to 28.0	32.04 titer Interval 27.0 to 38.0
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses B/Victoria Day 181	103.64 titer Interval 88.6 to 121.3	94.16 titer Interval 80.6 to 110.0	67.78 titer Interval 58.0 to 79.2	74.54 titer Interval 63.9 to 86.9

SECONDARY outcome

Timeframe: 180 days post-vaccination

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=110 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=110 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=113 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses A/H1N1 Day 181 HI GMR (aIIV4c/comparator group)	1.09 Ratio Interval 0.82 to 1.44	0.99 Ratio Interval 0.75 to 1.31	0.79 Ratio Interval 0.6 to 1.04	—
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses B/Yamagata Day 181 HI GMR (aIIV4c/comparator group)	1.04 Ratio Interval 0.82 to 1.32	1.47 Ratio Interval 1.16 to 1.87	1.08 Ratio Interval 0.86 to 1.37	—
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses B/Victoria Day 181 HI GMR (aIIV4c/comparator group)	1.10 Ratio Interval 0.89 to 1.36	1.53 Ratio Interval 1.23 to 1.9	1.39 Ratio Interval 1.12 to 1.72	—

SECONDARY outcome

Timeframe: 180 days post-vaccination

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=108 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=110 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=110 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=113 Participants RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses A/H1N1 Day 181	88.9 percentage of subjects Interval 81.4 to 94.1	87.3 percentage of subjects Interval 79.6 to 92.9	87.3 percentage of subjects Interval 79.6 to 92.9	87.6 percentage of subjects Interval 80.1 to 93.1
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses B/Yamagata Day 181	50.0 percentage of subjects Interval 40.2 to 59.8	50.0 percentage of subjects Interval 40.3 to 59.7	32.7 percentage of subjects Interval 24.1 to 42.3	52.2 percentage of subjects Interval 42.6 to 61.7
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses B/Victoria Day 181	93.5 percentage of subjects Interval 87.1 to 97.4	91.8 percentage of subjects Interval 85.0 to 96.2	77.3 percentage of subjects Interval 68.3 to 84.7	82.3 percentage of subjects Interval 74.0 to 88.8

SECONDARY outcome

Timeframe: 180 days post-vaccination

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=108 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=110 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=110 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=113 Participants RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses A/H1N1 Day 181	481.49 titer Interval 378.4 to 612.6	523.03 titer Interval 410.7 to 666.0	502.85 titer Interval 396.2 to 638.2	841.31 titer Interval 664.8 to 1064.7
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses A/H3N2 Day 181	68.72 titer Interval 56.9 to 83.1	68.17 titer Interval 56.5 to 82.3	54.35 titer Interval 45.0 to 65.6	100.14 titer Interval 83.2 to 120.5
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses B/Yamagata Day 181	24.46 titer Interval 21.5 to 27.8	24.98 titer Interval 22.0 to 28.4	21.82 titer Interval 19.2 to 24.8	28.17 titer Interval 24.8 to 32.0
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses B/Victoria Day 181	31.68 titer Interval 27.4 to 36.7	27.39 titer Interval 23.7 to 31.7	24.97 titer Interval 21.6 to 28.9	34.09 titer Interval 29.5 to 39.3

SECONDARY outcome

Timeframe: 180 days post-vaccination

Outcome measures

Outcome measures
Measure	Investigational aIIV4c Group n=110 Participants aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=110 Participants IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=113 Participants aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses A/H1N1 day 181 MN GMR (aIIV4c/comparator group)	0.92 ratio Interval 0.66 to 1.28	0.96 ratio Interval 0.69 to 1.33	0.57 ratio Interval 0.41 to 0.79	—
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses A/H3N2 Day 181 MN GMR (aIIV4c/comparator group)	1.01 ratio Interval 0.78 to 1.31	1.26 ratio Interval 0.98 to 1.64	0.69 ratio Interval 0.53 to 0.89	—
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses B/Yamagata Day 181 MN GMR (aIIV4c/comparator group)	0.98 ratio Interval 0.82 to 1.17	1.12 ratio Interval 0.94 to 1.34	0.87 ratio Interval 0.73 to 1.03	—
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses B/Victoria Day 181 MN GMR (aIIV4c/comparator group)	1.16 ratio Interval 0.95 to 1.41	1.27 ratio Interval 1.04 to 1.55	0.93 ratio Interval 0.76 to 1.13	—

Adverse Events

Investigational aIIV4c Group

Serious events: 2 serious events

Other events: 86 other events

Deaths: 1 deaths

Licensed IIV4c Group

Serious events: 1 serious events

Other events: 77 other events

Deaths: 0 deaths

Licensed aIIV4 Group

Serious events: 4 serious events

Other events: 84 other events

Deaths: 0 deaths

Licensed RIV4 Group

Serious events: 6 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Investigational aIIV4c Group n=116 participants at risk aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=119 participants at risk IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=116 participants at risk aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=120 participants at risk RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Gastrointestinal disorders Nausea	13.8% 16/116 • Number of events 16 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	10.1% 12/119 • Number of events 12 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	11.2% 13/116 • Number of events 13 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	12.5% 15/120 • Number of events 15 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
General disorders chills	12.9% 15/116 • Number of events 15 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	6.7% 8/119 • Number of events 8 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	10.3% 12/116 • Number of events 12 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	10.0% 12/120 • Number of events 12 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
General disorders fatigue	43.1% 50/116 • Number of events 50 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	24.4% 29/119 • Number of events 29 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	25.9% 30/116 • Number of events 30 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	33.3% 40/120 • Number of events 40 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
General disorders Induration	5.2% 6/116 • Number of events 6 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	4.2% 5/119 • Number of events 5 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	5.2% 6/116 • Number of events 6 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	3.3% 4/120 • Number of events 4 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
General disorders Injection site pain	60.3% 70/116 • Number of events 70 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	42.9% 51/119 • Number of events 51 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	56.9% 66/116 • Number of events 66 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	42.5% 51/120 • Number of events 51 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Metabolism and nutrition disorders loss of appetite	14.7% 17/116 • Number of events 17 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	10.9% 13/119 • Number of events 13 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	12.9% 15/116 • Number of events 15 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	16.7% 20/120 • Number of events 20 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Musculoskeletal and connective tissue disorders arthralgia	30.2% 35/116 • Number of events 35 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	16.0% 19/119 • Number of events 19 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	19.8% 23/116 • Number of events 23 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	23.3% 28/120 • Number of events 28 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Musculoskeletal and connective tissue disorders myalgia	34.5% 40/116 • Number of events 40 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	19.3% 23/119 • Number of events 23 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	22.4% 26/116 • Number of events 26 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	22.5% 27/120 • Number of events 27 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Nervous system disorders headache	31.9% 37/116 • Number of events 37 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	23.5% 28/119 • Number of events 28 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	25.0% 29/116 • Number of events 29 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	30.0% 36/120 • Number of events 36 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Skin and subcutaneous tissue disorders erythema	5.2% 6/116 • Number of events 6 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	3.4% 4/119 • Number of events 4 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	2.6% 3/116 • Number of events 3 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	1.7% 2/120 • Number of events 2 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.

Additional Information

Seqirus Clinical Trial Manager

Seqirus

Phone: 1-855-358-8966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Investigational aIIV4c Group n=116 participants at risk aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Licensed IIV4c Group n=119 participants at risk IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed aIIV4 Group n=116 participants at risk aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Licensed RIV4 Group n=120 participants at risk RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Cardiac disorders Atrioventricular block second degree	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.83% 1/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Cardiac disorders Cardiac failure congestive	0.86% 1/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Cardiac disorders Coronary artery stenosis	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.86% 1/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Cardiac disorders Ventricular tachycardia	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.84% 1/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.86% 1/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Immune system disorders Contrast media allergy	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.83% 1/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Infections and infestations COVID-19	0.86% 1/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.86% 1/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	1.7% 2/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Infections and infestations Scrotal abscess	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.83% 1/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Infections and infestations Sepsis	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.83% 1/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.86% 1/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.83% 1/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Nervous system disorders Cerebrovascular accident	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.86% 1/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Nervous system disorders Guillain-Barre syndrome	0.86% 1/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Renal and urinary disorders Acute kidney injury	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.83% 1/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Renal and urinary disorders Nephrolithiasis	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.83% 1/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.86% 1/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Vascular disorders Deep vein thrombosis	0.00% 0/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/119 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.86% 1/116 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	0.00% 0/120 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.