Trial Outcomes & Findings for Adjuvanted Seasonal Recombinant Quadrivalent Virus-Like Particles (QVLP) Influenza Vaccine in Adults 65 Years of Age and Older (NCT NCT04622592)

NCT ID: NCT04622592

Last Updated: 2023-07-21

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

209 participants

Primary outcome timeframe

Day 0 (pre-vaccination)

Results posted on

2023-07-21

Participant Flow

Participants were randomized at an equal ratio into 8 treatment groups to receive Quadrivalent Virus-Like Particles (QVLP) vaccine adjuvanted with AS03 (full and half dose), QVLP vaccine unadjuvanted or Fluzone HD Quad vaccine.

Participants were healthy adult males and females 65 years of age and older.

Participant milestones

Participant milestones
Measure	QVLP15+Full AS03 Participants received one intramuscular (IM) injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent virus-like particle (VLP) Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30+Full AS03 Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone high dose (HD) Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible)
Overall Study STARTED	19	9	42	19	23	13	41	43
Overall Study Vaccinated	19	9	42	19	23	13	41	43
Overall Study COMPLETED	18	9	38	16	21	13	38	36
Overall Study NOT COMPLETED	1	0	4	3	2	0	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	QVLP15+Full AS03 Participants received one intramuscular (IM) injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent virus-like particle (VLP) Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30+Full AS03 Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone high dose (HD) Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible)
Overall Study Death	0	1	0	0	0	1
Overall Study Lost to Follow-up	0	0	3	1	2	2
Overall Study Physician Decision	0	0	0	1	0	0
Overall Study Withdrawal by Subject	1	2	0	0	1	4
Overall Study Other than specified above	0	1	0	0	0	0

Baseline Characteristics

Adjuvanted Seasonal Recombinant Quadrivalent Virus-Like Particles (QVLP) Influenza Vaccine in Adults 65 Years of Age and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible)..	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).	Total n=209 Participants Total of all reporting groups
Age, Customized 65-74 years	14 Participants n=5 Participants	7 Participants n=7 Participants	33 Participants n=5 Participants	14 Participants n=4 Participants	17 Participants n=21 Participants	10 Participants n=10 Participants	33 Participants n=115 Participants	34 Participants n=24 Participants	162 Participants n=42 Participants
Age, Customized ≥75 years	5 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=10 Participants	8 Participants n=115 Participants	9 Participants n=24 Participants	47 Participants n=42 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	24 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	4 Participants n=10 Participants	24 Participants n=115 Participants	29 Participants n=24 Participants	115 Participants n=42 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants	9 Participants n=4 Participants	13 Participants n=21 Participants	9 Participants n=10 Participants	17 Participants n=115 Participants	14 Participants n=24 Participants	94 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants	1 Participants n=24 Participants	10 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	9 Participants n=7 Participants	40 Participants n=5 Participants	19 Participants n=4 Participants	23 Participants n=21 Participants	13 Participants n=10 Participants	37 Participants n=115 Participants	42 Participants n=24 Participants	199 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=24 Participants	5 Participants n=42 Participants
Race (NIH/OMB) 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	8 Participants n=42 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	8 Participants n=7 Participants	40 Participants n=5 Participants	18 Participants n=4 Participants	19 Participants n=21 Participants	13 Participants n=10 Participants	39 Participants n=115 Participants	42 Participants n=24 Participants	196 Participants n=42 Participants
Race (NIH/OMB) More than one race	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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Immunization History Both Influenza and Non-influenza	1 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	5 Participants n=115 Participants	8 Participants n=24 Participants	23 Participants n=42 Participants
Immunization History Only influenza	6 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants	4 Participants n=10 Participants	15 Participants n=115 Participants	15 Participants n=24 Participants	74 Participants n=42 Participants
Immunization History Only non-influenza	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants	2 Participants n=24 Participants	12 Participants n=42 Participants
Immunization History None	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants	13 Participants n=4 Participants	13 Participants n=21 Participants	8 Participants n=10 Participants	18 Participants n=115 Participants	18 Participants n=24 Participants	100 Participants n=42 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination)

Population: Per protocol (PP) set included participants with a Day 0 and any post-vaccination immunogenicity assessment who completed the study with no major protocol deviations related to participant eligibility, the ability to develop a valid immune response, prohibited medication use, or the immunogenicity analyses; and who received QVLP or the active comparators.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=38 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=21 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=37 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=39 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 H1N1	69.1840 titers Interval 49.7233 to 96.2612	60.7941 titers Interval 38.1065 to 96.9894	87.5704 titers Interval 54.8902 to 139.7076	71.2385 titers Interval 36.1378 to 140.4323	65.5830 titers Interval 42.0562 to 102.2709	52.1449 titers Interval 29.6458 to 91.7193	80.6590 titers Interval 57.7141 to 112.72	71.9561 titers Interval 51.9366 to 99.692
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 H3N2	53.5390 titers Interval 33.539 to 85.4653	28.2789 titers Interval 14.5951 to 54.7919	42.9963 titers Interval 22.191 to 83.3079	35.6256 titers Interval 13.6267 to 93.1394	26.8632 titers Interval 14.3194 to 50.3954	57.9959 titers Interval 26.0689 to 129.0241	53.9648 titers Interval 33.5942 to 86.6876	50.3624 titers Interval 31.7401 to 79.9107
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 B/Yamagata lineage	35.1259 titers Interval 21.9677 to 56.1656	24.8494 titers Interval 12.795 to 48.2607	27.2713 titers Interval 14.042 to 52.9642	58.7285 titers Interval 22.3868 to 154.0659	23.9640 titers Interval 12.7454 to 45.0573	21.0585 titers Interval 9.4388 to 46.9827	31.8921 titers Interval 19.82 to 51.3171	31.1646 titers Interval 19.6087 to 49.5307
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 B/Victoria lineage	46.6653 titers Interval 30.7568 to 70.8021	21.1180 titers Interval 11.7113 to 38.0803	32.6846 titers Interval 18.1258 to 58.9372	38.5215 titers Interval 16.356 to 90.7256	36.7938 titers Interval 21.0003 to 64.4648	61.2554 titers Interval 30.0331 to 124.9366	36.3962 titers Interval 23.8547 to 55.5314	26.5681 titers Interval 17.6053 to 40.0937

PRIMARY outcome

Timeframe: Day 28

Population: Participants in PP Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=38 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=20 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=34 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=39 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 H1N1	222.1740 titers Interval 157.4823 to 313.4401	168.9548 titers Interval 103.8485 to 274.8785	296.2330 titers Interval 179.6681 to 488.4226	419.3985 titers Interval 206.782 to 850.6303	174.3779 titers Interval 108.5108 to 280.2268	214.6073 titers Interval 119.1544 to 386.5261	165.0534 titers Interval 114.7138 to 237.4834	208.8559 titers Interval 148.701 to 293.3456
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 H3N2	399.5021 titers Interval 259.4647 to 615.1201	319.7171 titers Interval 173.6539 to 588.6365	205.4037 titers Interval 109.7143 to 384.5505	217.8171 titers Interval 89.73 to 528.7448	255.5949 titers Interval 140.9883 to 463.3632	355.9261 titers Interval 170.1736 to 744.4362	369.0050 titers Interval 233.8149 to 582.3613	352.6912 titers Interval 230.3416 to 540.0285
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 B/Yamagata lineage	108.9616 titers Interval 72.1607 to 164.5304	48.0076 titers Interval 26.8043 to 85.9836	95.0432 titers Interval 52.2252 to 172.9667	117.6911 titers Interval 50.4649 to 274.4718	67.2848 titers Interval 38.1259 to 118.7446	58.0067 titers Interval 28.674 to 117.3459	59.0477 titers Interval 38.194 to 91.2874	137.4894 titers Interval 91.5389 to 206.5059
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 B/Victoria lineage	121.7513 titers Interval 84.4092 to 175.6135	81.3894 titers Interval 48.483 to 136.6302	91.4846 titers Interval 53.7284 to 155.7729	76.9675 titers Interval 36.2594 to 163.3783	81.3375 titers Interval 49.0918 to 134.7638	113.1054 titers Interval 60.4641 to 211.5776	67.2196 titers Interval 45.6367 to 99.0097	114.1339 titers Interval 79.503 to 163.8498

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: Participants in PP Set with available data were analyzed.

Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. \< 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 28 was measured using an HI assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=38 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=20 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=34 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=39 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 H1N1	36.8 percentage of participants Interval 21.81 to 54.01	42.1 percentage of participants Interval 20.25 to 66.5	38.9 percentage of participants Interval 17.3 to 64.25	55.6 percentage of participants Interval 21.2 to 86.3	25.0 percentage of participants Interval 8.66 to 49.1	30.8 percentage of participants Interval 9.09 to 61.43	29.4 percentage of participants Interval 15.1 to 47.48	38.5 percentage of participants Interval 23.36 to 55.38
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 H3N2	65.8 percentage of participants Interval 48.65 to 80.37	63.2 percentage of participants Interval 38.36 to 83.71	38.9 percentage of participants Interval 17.3 to 64.25	55.6 percentage of participants Interval 21.2 to 86.3	70.0 percentage of participants Interval 45.72 to 88.11	61.5 percentage of participants Interval 31.58 to 86.14	47.1 percentage of participants Interval 29.78 to 64.87	64.1 percentage of participants Interval 47.18 to 78.8
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 B/Yamagata lineage	31.6 percentage of participants Interval 17.5 to 48.65	21.1 percentage of participants Interval 6.05 to 45.57	33.3 percentage of participants Interval 13.34 to 59.01	22.2 percentage of participants Interval 2.81 to 60.01	30.0 percentage of participants Interval 11.89 to 54.28	30.8 percentage of participants Interval 9.09 to 61.43	14.7 percentage of participants Interval 4.95 to 31.06	38.5 percentage of participants Interval 23.36 to 55.38
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 B/Victoria lineage	26.3 percentage of participants Interval 13.4 to 43.1	36.8 percentage of participants Interval 16.29 to 61.64	44.4 percentage of participants Interval 21.53 to 69.24	33.3 percentage of participants Interval 7.49 to 70.07	30.0 percentage of participants Interval 11.89 to 54.28	15.4 percentage of participants Interval 1.92 to 45.45	23.5 percentage of participants Interval 10.75 to 41.17	46.2 percentage of participants Interval 30.09 to 62.82

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: Participants in PP Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=38 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=20 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=34 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=39 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 H1N1	100 percentage of participants Interval 90.75 to 100.0	94.7 percentage of participants Interval 73.97 to 99.87	100 percentage of participants Interval 81.47 to 100.0	100 percentage of participants Interval 66.37 to 100.0	90.0 percentage of participants Interval 68.3 to 98.77	100 percentage of participants Interval 75.29 to 100.0	100 percentage of participants Interval 89.72 to 100.0	100 percentage of participants Interval 90.97 to 100.0
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 H3N2	97.4 percentage of participants Interval 86.19 to 99.93	94.7 percentage of participants Interval 73.97 to 99.87	88.9 percentage of participants Interval 65.29 to 98.62	88.9 percentage of participants Interval 51.75 to 99.72	100 percentage of participants Interval 83.16 to 100.0	100 percentage of participants Interval 75.29 to 100.0	97.1 percentage of participants Interval 84.67 to 99.93	92.3 percentage of participants Interval 79.13 to 98.38
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 B/Yamagata lineage	76.3 percentage of participants Interval 59.76 to 88.56	63.2 percentage of participants Interval 38.36 to 83.71	77.8 percentage of participants Interval 52.36 to 93.59	88.9 percentage of participants Interval 51.75 to 99.72	80.0 percentage of participants Interval 56.34 to 94.27	76.9 percentage of participants Interval 46.19 to 94.96	67.6 percentage of participants Interval 49.47 to 82.61	89.7 percentage of participants Interval 75.78 to 97.13
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 B/Victoria lineage	97.4 percentage of participants Interval 86.19 to 99.93	68.4 percentage of participants Interval 43.45 to 87.42	88.9 percentage of participants Interval 65.29 to 98.62	77.8 percentage of participants Interval 39.99 to 97.19	80.0 percentage of participants Interval 56.34 to 94.27	84.6 percentage of participants Interval 54.55 to 98.08	82.4 percentage of participants Interval 65.47 to 93.24	89.7 percentage of participants Interval 75.78 to 97.13

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination), Day 28

Population: Participants in PP Set with available data were analyzed.

GMFR, the geometric mean of the ratio of GMTs (Day 28/Day 0) in each treatment group was measured using an HI assay for the homologous strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=38 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=20 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=34 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=39 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) B/Victoria lineage	3.0230 ratio Interval 2.2264 to 4.1046	2.9769 ratio Interval 1.9293 to 4.5934	2.7180 ratio Interval 1.7465 to 4.2299	2.0988 ratio Interval 1.1229 to 3.9228	2.2729 ratio Interval 1.4941 to 3.4576	2.4588 ratio Interval 1.4564 to 4.1511	1.8734 ratio Interval 1.3579 to 2.5846	3.7317 ratio Interval 2.7594 to 5.0465
Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) H1N1	3.2024 ratio Interval 2.3211 to 4.4183	2.5570 ratio Interval 1.6213 to 4.0326	4.0142 ratio Interval 2.5134 to 6.4112	5.9788 ratio Interval 3.0859 to 11.5835	2.5408 ratio Interval 1.6304 to 3.9597	3.4414 ratio Interval 1.9819 to 5.9757	2.3058 ratio Interval 1.6405 to 3.241	2.9661 ratio Interval 2.1587 to 4.0755
Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) H3N2	8.4563 ratio Interval 5.5885 to 12.7956	8.0508 ratio Interval 4.4716 to 14.4949	4.7572 ratio Interval 2.6074 to 8.6794	5.1509 ratio Interval 2.2007 to 12.0561	6.3791 ratio Interval 3.5973 to 11.3124	7.3718 ratio Interval 3.632 to 14.9624	7.6527 ratio Interval 4.9365 to 11.8637	7.5907 ratio Interval 5.0451 to 11.4208
Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) B/Yamagata lineage	3.3189 ratio Interval 2.395 to 4.5993	1.7591 ratio Interval 1.109 to 2.7904	3.3872 ratio Interval 2.109 to 5.4401	2.7245 ratio Interval 1.39 to 5.3402	2.5016 ratio Interval 1.5953 to 3.9227	2.3219 ratio Interval 1.3284 to 4.0586	1.8422 ratio Interval 1.3051 to 2.6005	4.4642 ratio Interval 3.2361 to 6.1584

PRIMARY outcome

Timeframe: Up to 30 minutes post-vaccination

Population: SAS.

An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One Immediate Adverse Event (AE)	4 Participants	3 Participants	1 Participants	0 Participants	5 Participants	1 Participants	5 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to 30 minutes post-vaccination

Population: Participants in SAS with at least one immediate AE.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=4 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=3 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=1 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=5 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=1 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=5 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=4 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 Immediate solicited AE Grade 1	4 Participants	3 Participants	1 Participants	0 Participants	4 Participants	1 Participants	4 Participants	4 Participants
Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 Immediate solicited AE Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 Immediate solicited AE Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 Immediate solicited AE Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 30 minutes post-vaccination

Population: Participants in SAS with at least one immediate AE.

An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. A related AE is an event where the investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related" or "Definitely Related". If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. The causal relationship of all solicited local and systemic AEs was considered related to vaccination. Participants with any related AE was reported.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=4 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=3 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=1 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=5 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=1 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=5 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=4 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One Immediate AE Related to Vaccination Related immediate solicited AE	4 Participants	3 Participants	1 Participants	0 Participants	5 Participants	1 Participants	5 Participants	4 Participants
Number of Participants With at Least One Immediate AE Related to Vaccination Related immediate unsolicited AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 7

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7	37 Participants	12 Participants	12 Participants	5 Participants	14 Participants	8 Participants	26 Participants	25 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 7

Population: Participants in SAS with at least one solicited local or systemic AE.

An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=37 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=12 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=12 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=5 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=14 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=8 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=26 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=25 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 Solicited AE of Grade 4	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 Solicited AE of Grade 1	21 Participants	8 Participants	8 Participants	3 Participants	5 Participants	7 Participants	16 Participants	16 Participants
Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 Solicited AE of Grade 2	13 Participants	4 Participants	3 Participants	2 Participants	7 Participants	1 Participants	7 Participants	5 Participants
Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 Solicited AE of Grade 3	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	4 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28	6 Participants	3 Participants	6 Participants	4 Participants	1 Participants	0 Participants	8 Participants	7 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: Participants in SAS with at least one unsolicited AE.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=6 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=3 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=6 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=4 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=1 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=8 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=7 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 Unsolicited AE Grade 1	1 Participants	3 Participants	3 Participants	1 Participants	0 Participants	0 Participants	4 Participants	2 Participants
Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 Unsolicited AE Grade 2	4 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	4 Participants	4 Participants
Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 Unsolicited AE Grade 3	1 Participants	0 Participants	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 Unsolicited AE Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: Participants in SAS with at least one unsolicited AE.

An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. A related AE was an event where the Investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related" or "Definitely Related". If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. Participants with any related AE were reported.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=6 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=3 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=6 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=4 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=1 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=8 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=7 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28	2 Participants	0 Participants	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 28

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 28

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 28

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 28

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28	3 Participants	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants	7 Participants	7 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 28

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 28

Population: SAS.

The number of participants in each treatment group with an occurrence of death was assessed.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With the Occurrence of Death From Day 1 up to Day 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 29 up to Day 182

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One SAE From Day 29 up to Day 182	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	5 Participants

PRIMARY outcome

Timeframe: Day 29 up to Day 182

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 29 up to Day 182

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One AESI From Day 29 up to Day 182	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 29 up to Day 182

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One MAAE From Day 29 up to Day 182	14 Participants	3 Participants	3 Participants	1 Participants	2 Participants	2 Participants	6 Participants	12 Participants

PRIMARY outcome

Timeframe: Day 29 up to Day 182

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One New NOCD From Day 29 up to Day 182	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 29 up to Day 182

Population: SAS.

The number of participants in each treatment group with an occurrence of death was assessed.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With an Occurrence of Death From Day 29 up to Day 182	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 183 up to the end of study (Day 365)

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One SAE From Day 183 up to Day 365	6 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Day 183 up to the end of study (Day 365)

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 183 up to the end of study (Day 365)

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One AESI From Day 183 up to Day 365	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 183 up to the end of study (Day 365)

Population: SAS.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One MAAE From Day 183 up to Day 365	8 Participants	4 Participants	3 Participants	2 Participants	0 Participants	3 Participants	5 Participants	4 Participants

PRIMARY outcome

Timeframe: Day 183 up to the end of study (Day 365)

Population: SAS.

All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility should be interpreted broadly; the only clear exceptions are degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases should be reported.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With at Least One NOCD From Day 183 up to Day 365	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 183 up to the end of study (Day 365)

Population: SAS.

The number of participants in each treatment group with an occurrence of death was assessed.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With an Occurrence of Death From Day 183 up to Day 365	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination)

Population: SAS. Only participants with at least one clinically significant laboratory parameter are reported.

Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as "clinically significant" or "not clinically significant" by the site investigator, with appropriate documentation.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 3

Population: SAS. Only participants with at least one clinically significant abnormal laboratory finding are reported.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 Urine glucose - abnormal, clinically significant	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 Urine occult blood - abnormal, clinically significant	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 Urine protein - abnormal, clinically significant	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 Urine specimen appearance - abnormal, clinically significant	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 28

Population: SAS. Only participants with at least one clinically significant abnormal laboratory finding are reported.

Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, and pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, and platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, cholesterol, phosphate, potassium, protein, sodium, triglycerides, and urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as "clinically significant" or "not clinically significant" by the site investigator, with appropriate documentation.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=42 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 Urine occult blood - abnormal, clinically significant	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 Urine protein - abnormal, clinically significant	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 Urine specimen appearance - abnormal, clinically significant	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 182, Day 365

Population: Participants in PP Set with available data at each time point were analyzed.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=37 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=21 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=34 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=33 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 H3N2: Day 182	178.9880 titers Interval 112.9393 to 283.6629	129.5061 titers Interval 66.9232 to 250.6131	119.5465 titers Interval 62.8739 to 227.3021	153.9351 titers Interval 60.515 to 391.5723	99.1267 titers Interval 53.7954 to 182.6569	220.4298 titers Interval 101.3667 to 479.3418	219.2384 titers Interval 135.6131 to 354.4308	131.0605 titers Interval 80.4859 to 213.4146
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 H3N2: Day 365	189.1376 titers Interval 114.9632 to 311.1694	210.9250 titers Interval 103.1083 to 431.4819	156.9806 titers Interval 81.6759 to 301.7156	217.4477 titers Interval 86.3116 to 547.8233	141.6148 titers Interval 76.1935 to 263.2082	265.6521 titers Interval 123.1469 to 573.0639	254.8805 titers Interval 156.1431 to 416.0547	135.1917 titers Interval 82.1734 to 222.4177
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 H1N1: Day 182	175.6786 titers Interval 120.2111 to 256.7397	129.4173 titers Interval 75.1194 to 222.9628	226.2152 titers Interval 133.224 to 384.1147	332.5919 titers Interval 154.1053 to 717.8036	118.8437 titers Interval 71.8225 to 196.6492	214.5054 titers Interval 113.0981 to 406.8378	164.9504 titers Interval 111.0359 to 245.0435	121.7951 titers Interval 81.4995 to 182.014
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 H1N1: Day 365	97.7443 titers Interval 64.3983 to 148.3572	103.0787 titers Interval 56.5787 to 187.7954	145.2654 titers Interval 84.0127 to 251.1768	160.1136 titers Interval 73.808 to 347.3383	109.2066 titers Interval 64.9584 to 183.5956	156.0724 titers Interval 81.9383 to 297.2795	124.5817 titers Interval 82.6212 to 187.8527	79.1142 titers Interval 52.124 to 120.0802
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 B/Yamagata lineage: Day 182	50.0023 titers Interval 33.063 to 75.6203	33.5742 titers Interval 18.5541 to 60.7534	45.3843 titers Interval 25.4806 to 80.8353	83.0475 titers Interval 35.8984 to 192.1226	30.1800 titers Interval 17.4285 to 52.2611	33.1521 titers Interval 16.4982 to 66.6173	46.0555 titers Interval 29.914 to 70.9067	51.3900 titers Interval 33.163 to 79.6348
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 B/Yamagata lineage: Day 365	32.2612 titers Interval 20.6025 to 50.5174	34.7689 titers Interval 18.2475 to 66.2486	38.5246 titers Interval 21.3868 to 69.3952	65.9800 titers Interval 28.7046 to 151.6606	30.8130 titers Interval 17.6303 to 53.8529	24.0753 titers Interval 12.0453 to 48.12	45.4888 titers Interval 29.2558 to 70.7291	45.1481 titers Interval 28.8323 to 70.6969
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 B/Victoria lineage: Day 182	59.2611 titers Interval 41.6653 to 84.2879	39.9246 titers Interval 24.0928 to 66.1598	33.2709 titers Interval 20.3499 to 54.3959	44.8356 titers Interval 21.9488 to 91.5873	42.7246 titers Interval 26.7668 to 68.196	52.2104 titers Interval 28.8168 to 94.5952	37.2192 titers Interval 25.773 to 53.7489	43.4396 titers Interval 29.9146 to 63.0796
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 B/Victoria lineage: Day 365	55.2532 titers Interval 37.5128 to 81.3833	31.7135 titers Interval 18.175 to 55.3369	40.6922 titers Interval 24.4797 to 67.6421	44.9239 titers Interval 21.8954 to 92.1727	39.9398 titers Interval 24.6619 to 64.6823	50.8227 titers Interval 27.9482 to 92.419	49.0601 titers Interval 33.5119 to 71.8221	39.9694 titers Interval 27.1362 to 58.8715

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 182 and up to Day 365

Population: Participants in PP Set with available data at each timepoint were analyzed.

Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 182 and Day 0 and Day 365 or a rise of undetectable HI titer (i.e. \<10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 182 and Day 365 was measured using an HI assay for the following homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=37 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=21 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=34 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=33 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 H1N1: Day 182	16.2 percentage of participants Interval 6.19 to 32.01	27.8 percentage of participants Interval 9.69 to 53.48	36.8 percentage of participants Interval 16.29 to 61.64	55.6 percentage of participants Interval 21.2 to 86.3	28.6 percentage of participants Interval 11.28 to 52.18	38.5 percentage of participants Interval 13.86 to 68.42	29.4 percentage of participants Interval 15.1 to 47.48	27.3 percentage of participants Interval 13.3 to 45.52
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 H1N1: Day 365	22.6 percentage of participants Interval 9.59 to 41.1	26.7 percentage of participants Interval 7.79 to 55.1	27.8 percentage of participants Interval 9.69 to 53.48	33.3 percentage of participants Interval 7.49 to 70.07	25.0 percentage of participants Interval 8.66 to 49.1	38.5 percentage of participants Interval 13.86 to 68.42	12.5 percentage of participants Interval 3.51 to 28.99	12.9 percentage of participants Interval 3.63 to 29.83
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 H3N2: Day 182	32.4 percentage of participants Interval 18.01 to 49.79	50.0 percentage of participants Interval 26.02 to 73.98	31.6 percentage of participants Interval 12.58 to 56.55	55.6 percentage of participants Interval 21.2 to 86.3	42.9 percentage of participants Interval 21.82 to 65.98	38.5 percentage of participants Interval 13.86 to 68.42	47.1 percentage of participants Interval 29.78 to 64.87	45.5 percentage of participants Interval 28.11 to 63.65
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 H3N2: Day 365	38.7 percentage of participants Interval 21.85 to 57.81	46.7 percentage of participants Interval 21.27 to 73.41	38.9 percentage of participants Interval 17.3 to 64.25	44.4 percentage of participants Interval 13.7 to 78.8	60.0 percentage of participants Interval 36.05 to 80.88	61.5 percentage of participants Interval 31.58 to 86.14	53.1 percentage of participants Interval 34.74 to 70.91	45.2 percentage of participants Interval 27.32 to 63.97
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 B/Yamagata lineage: Day 182	13.5 percentage of participants Interval 4.54 to 28.77	0 percentage of participants Interval 0.0 to 18.53	15.8 percentage of participants Interval 3.38 to 39.58	11.1 percentage of participants Interval 0.28 to 48.25	9.5 percentage of participants Interval 1.17 to 30.38	7.7 percentage of participants Interval 0.19 to 36.03	17.6 percentage of participants Interval 6.76 to 34.53	24.2 percentage of participants Interval 11.09 to 42.26
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 B/Yamagata lineage: Day 365	9.7 percentage of participants Interval 2.04 to 25.75	6.7 percentage of participants Interval 0.17 to 31.95	11.1 percentage of participants Interval 1.38 to 34.71	11.1 percentage of participants Interval 0.28 to 48.25	15.0 percentage of participants Interval 3.21 to 37.89	0 percentage of participants Interval 0.0 to 24.71	3.1 percentage of participants Interval 0.08 to 16.22	19.4 percentage of participants Interval 7.45 to 37.47
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 B/Victoria lineage: Day 182	13.5 percentage of participants Interval 4.54 to 28.77	22.2 percentage of participants Interval 6.41 to 47.64	5.3 percentage of participants Interval 0.13 to 26.03	22.2 percentage of participants Interval 2.81 to 60.01	19.0 percentage of participants Interval 5.45 to 41.91	0 percentage of participants Interval 0.0 to 24.71	5.9 percentage of participants Interval 0.72 to 19.68	21.2 percentage of participants Interval 8.98 to 38.91
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 B/Victoria lineage: Day 365	9.7 percentage of participants Interval 2.04 to 25.75	20.0 percentage of participants Interval 4.33 to 48.09	5.6 percentage of participants Interval 0.14 to 27.29	22.2 percentage of participants Interval 2.81 to 60.01	5.0 percentage of participants Interval 0.13 to 24.87	0 percentage of participants Interval 0.0 to 24.71	3.1 percentage of participants Interval 0.08 to 16.22	16.1 percentage of participants Interval 5.45 to 33.73

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 182 and up to Day 365

Population: Participants in PP Set with available data at each timepoint were analyzed.

Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 182 and on Day 365 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage)

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=37 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=21 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=34 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=33 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 H1N1: Day 182	94.6 percentage of participants Interval 81.81 to 99.34	94.4 percentage of participants Interval 72.71 to 99.86	100 percentage of participants Interval 82.35 to 100.0	100 percentage of participants Interval 66.37 to 100.0	81.0 percentage of participants Interval 58.09 to 94.55	100 percentage of participants Interval 75.29 to 100.0	94.1 percentage of participants Interval 80.32 to 99.28	97.0 percentage of participants Interval 84.24 to 99.92
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 H1N1: Day 365	22.6 percentage of participants Interval 9.59 to 41.1	26.7 percentage of participants Interval 7.79 to 55.1	27.8 percentage of participants Interval 9.69 to 53.48	33.3 percentage of participants Interval 7.49 to 70.07	25.0 percentage of participants Interval 8.66 to 49.1	38.5 percentage of participants Interval 13.86 to 68.42	12.5 percentage of participants Interval 3.51 to 28.99	12.9 percentage of participants Interval 3.63 to 29.83
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 H3N2: Day 182	94.6 percentage of participants Interval 81.81 to 99.34	83.3 percentage of participants Interval 58.58 to 96.42	89.5 percentage of participants Interval 66.86 to 98.7	88.9 percentage of participants Interval 51.75 to 99.72	90.5 percentage of participants Interval 69.62 to 98.83	100 percentage of participants Interval 75.29 to 100.0	91.2 percentage of participants Interval 76.32 to 98.14	84.8 percentage of participants Interval 68.1 to 94.89
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 H3N2: Day 365	38.7 percentage of participants Interval 21.85 to 57.81	46.7 percentage of participants Interval 21.27 to 73.41	38.9 percentage of participants Interval 17.3 to 64.25	44.4 percentage of participants Interval 13.7 to 78.8	60.0 percentage of participants Interval 36.05 to 80.88	61.5 percentage of participants Interval 31.58 to 86.14	53.1 percentage of participants Interval 34.74 to 70.91	45.2 percentage of participants Interval 27.32 to 63.97
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 B/Yamagata lineage: Day 182	62.2 percentage of participants Interval 44.76 to 77.54	50.0 percentage of participants Interval 26.02 to 73.98	57.9 percentage of participants Interval 33.5 to 79.75	88.9 percentage of participants Interval 51.75 to 99.72	38.1 percentage of participants Interval 18.11 to 61.56	46.2 percentage of participants Interval 19.22 to 74.87	58.8 percentage of participants Interval 40.7 to 75.35	69.7 percentage of participants Interval 51.29 to 84.41
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 B/Yamagata lineage: Day 365	9.7 percentage of participants Interval 2.04 to 25.75	6.7 percentage of participants Interval 0.17 to 31.95	11.1 percentage of participants Interval 1.38 to 34.71	11.1 percentage of participants Interval 0.28 to 48.25	15.0 percentage of participants Interval 3.21 to 37.89	0 percentage of participants Interval 0.0 to 24.71	3.1 percentage of participants Interval 0.08 to 16.22	19.4 percentage of participants Interval 7.45 to 37.47
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 B/Victoria lineage: Day 182	75.7 percentage of participants Interval 58.8 to 88.23	50.0 percentage of participants Interval 26.02 to 73.98	47.4 percentage of participants Interval 24.45 to 71.14	77.8 percentage of participants Interval 39.99 to 97.19	66.7 percentage of participants Interval 43.03 to 85.41	69.2 percentage of participants Interval 38.57 to 90.91	61.8 percentage of participants Interval 43.56 to 77.83	66.7 percentage of participants Interval 48.17 to 82.04
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 B/Victoria lineage: Day 365	9.7 percentage of participants Interval 2.04 to 25.75	20.0 percentage of participants Interval 4.33 to 48.09	5.6 percentage of participants Interval 0.14 to 27.29	22.2 percentage of participants Interval 2.81 to 60.01	5.0 percentage of participants Interval 0.13 to 24.87	0 percentage of participants Interval 0.0 to 24.71	3.1 percentage of participants Interval 0.08 to 16.22	16.1 percentage of participants Interval 5.45 to 33.73

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Day 182, Day 365

Population: Participants in PP Set with available data at each timepoint were analyzed.

GMFR: the geometric mean of the ratio of GMTs (Day 182/Day 0 and Day 365/Day 0) measured using an HI assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=37 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=21 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=34 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=33 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) H1N1: Day 182/Day 0	2.4366 ratio Interval 1.734 to 3.4239	1.9075 ratio Interval 1.171 to 3.1072	2.8586 ratio Interval 1.7764 to 4.5999	4.6671 ratio Interval 2.3416 to 9.3021	1.7392 ratio Interval 1.1071 to 2.7322	1.9829 ratio Interval 1.9829 to 6.2724	2.1950 ratio Interval 1.5387 to 3.131	1.7267 ratio Interval 1.2044 to 2.4754
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) H1N1: Day 365/Day 0	1.6031 ratio Interval 1.138 to 2.2583	1.6790 ratio Interval 1.0269 to 2.7451	1.7840 ratio Interval 1.1381 to 2.7964	2.2667 ratio Interval 1.2027 to 4.272	1.6075 ratio Interval 1.0508 to 2.4592	2.7253 ratio Interval 1.6057 to 4.6254	1.5400 ratio Interval 1.0986 to 2.1588	1.1081 ratio Interval 0.7875 to 1.5593
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) H3N2: Day 182/Day 0	3.7985 ratio Interval 2.4701 to 5.8414	3.6059 ratio Interval 1.9379 to 6.7095	2.7326 ratio Interval 1.5003 to 4.9771	3.7625 ratio Interval 1.5737 to 8.9954	2.6792 ratio Interval 1.5087 to 4.7577	4.5291 ratio Interval 2.1919 to 9.3586	4.6788 ratio Interval 2.987 to 7.3287	2.7380 ratio Interval 1.7355 to 4.3198
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) H3N2: Day 365/Day 0	4.0557 ratio Interval 2.5792 to 6.3774	5.5988 ratio Interval 2.9159 to 10.7504	3.5029 ratio Interval 1.9348 to 6.3418	5.3618 ratio Interval 2.315 to 12.4188	4.0497 ratio Interval 2.2937 to 7.1501	5.3933 ratio Interval 2.6799 to 10.854	5.2951 ratio Interval 3.3896 to 8.2719	2.8866 ratio Interval 1.8356 to 4.5393
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) B/Yamagata lineage: Day 182/Day 0	1.4557 ratio Interval 1.0841 to 1.9546	1.2508 ratio Interval 0.82 to 1.908	1.5914 ratio Interval 1.0554 to 2.3995	1.8261 ratio Interval 1.0027 to 3.3256	1.1448 ratio Interval 0.7742 to 1.6928	2.2374 ratio Interval 0.8272 to 2.2374	1.5232 ratio Interval 1.1206 to 2.0704	1.5720 ratio Interval 1.1511 to 2.147
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) B/Yamagata lineage: Day 365/Day 0	1.1944 ratio Interval 0.8731 to 1.6338	1.2518 ratio Interval 0.7983 to 1.963	1.3110 ratio Interval 0.8696 to 1.9765	1.4345 ratio Interval 0.8 to 2.5722	1.1462 ratio Interval 0.7761 to 1.6926	0.9986 ratio Interval 0.6153 to 1.6207	1.3226 ratio Interval 0.9716 to 1.8005	1.3422 ratio Interval 0.9813 to 1.8358
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) B/Victoria lineage: Day 182/Day 0	1.3892 ratio Interval 1.0824 to 1.783	1.4917 ratio Interval 1.0429 to 2.1338	0.9854 ratio Interval 0.697 to 1.393	1.2056 ratio Interval 0.7291 to 1.9937	1.1803 ratio Interval 0.8492 to 1.6405	1.0689 ratio Interval 0.7015 to 1.6287	1.1041 ratio Interval 0.8523 to 1.4303	1.4098 ratio Interval 1.0833 to 1.8346
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) B/Victoria lineage: Day 365/Day 0	1.3199 ratio Interval 1.0153 to 1.7159	1.2063 ratio Interval 0.8261 to 1.7615	1.1788 ratio Interval 0.8363 to 1.6615	1.1979 ratio Interval 0.7372 to 1.9463	1.1095 ratio Interval 0.8012 to 1.5365	1.0238 ratio Interval 0.6819 to 1.5371	1.2542 ratio Interval 0.9693 to 1.6229	1.3656 ratio Interval 1.0496 to 1.7767

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Day 28

Population: Participants in PP Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=38 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=21 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=37 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=39 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
GMTs of HI Antibody Response for Each Heterologous Influenza Strain H1N1: Day 0	57.0448 titers Interval 35.538 to 91.5672	29.8495 titers Interval 15.2856 to 58.2896	90.8941 titers Interval 46.5459 to 177.4963	60.8920 titers Interval 23.0277 to 161.0166	45.6156 titers Interval 24.1349 to 86.2145	35.0221 titers Interval 15.5941 to 78.6549	58.6793 titers Interval 36.3248 to 94.7911	36.2950 titers Interval 22.7497 to 57.9053
GMTs of HI Antibody Response for Each Heterologous Influenza Strain H1N1: Day 28	191.9608 titers Interval 122.9439 to 299.7219	90.8596 titers Interval 48.3851 to 170.6197	290.5308 titers Interval 152.0669 to 555.0723	418.9367 titers Interval 167.6995 to 1046.5621	107.3121 titers Interval 58.0657 to 198.3253	168.6130 titers Interval 78.7144 to 361.1836	141.5521 titers Interval 88.378 to 226.7192	210.6752 titers Interval 135.7077 to 327.0561
GMTs of HI Antibody Response for Each Heterologous Influenza Strain H3N2: Day 0	32.0958 titers Interval 20.389 to 50.5243	17.5909 titers Interval 9.2601 to 33.4167	38.5796 titers Interval 20.3087 to 73.2878	21.6012 titers Interval 8.503 to 54.876	16.9318 titers Interval 9.1967 to 31.1729	30.5442 titers Interval 14.0614 to 66.3484	40.3477 titers Interval 25.4754 to 63.9023	25.6289 titers Interval 16.3764 to 40.1088
GMTs of HI Antibody Response for Each Heterologous Influenza Strain H3N2: Day 28	79.9144 titers Interval 50.3858 to 126.7481	47.9629 titers Interval 24.9813 to 92.0864	89.5835 titers Interval 45.8327 to 175.098	56.5609 titers Interval 21.9233 to 145.9243	36.6176 titers Interval 19.3898 to 69.1524	48.0514 titers Interval 21.8386 to 105.7274	108.5069 titers Interval 66.6323 to 176.6971	121.5473 titers Interval 77.0928 to 191.6358
GMTs of HI Antibody Response for Each Heterologous Influenza Strain B/Victoria lineage: Day 0	34.2028 titers Interval 22.637 to 51.6779	14.9040 titers Interval 8.3141 to 26.7171	22.6953 titers Interval 12.6605 to 40.684	38.4838 titers Interval 16.4805 to 89.864	18.0797 titers Interval 10.3771 to 31.4995	18.4484 titers Interval 9.1098 to 37.3602	26.9646 titers Interval 17.7478 to 40.9677	14.8765 titers Interval 9.8986 to 22.3579
GMTs of HI Antibody Response for Each Heterologous Influenza Strain B/Victoria lineage: Day 28	65.9266 titers Interval 44.8718 to 96.8606	22.2497 titers Interval 12.913 to 38.3371	39.2478 titers Interval 22.4411 to 68.6416	58.8887 titers Interval 26.7117 to 129.8263	31.8255 titers Interval 18.7268 to 54.0865	27.5162 titers Interval 14.2535 to 53.1199	45.6899 titers Interval 30.4213 to 68.6218	59.6513 titers Interval 40.8027 to 87.2069

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: Participants in PP Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=38 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=20 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=34 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=39 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain H1N1	36.8 percentage of participants Interval 21.81 to 54.01	31.6 percentage of participants Interval 12.58 to 56.55	33.3 percentage of participants Interval 13.34 to 59.01	55.6 percentage of participants Interval 21.2 to 86.3	25.0 percentage of participants Interval 8.66 to 49.1	38.5 percentage of participants Interval 13.86 to 68.42	29.4 percentage of participants Interval 15.1 to 47.48	53.8 percentage of participants Interval 37.18 to 69.91
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain H3N2	18.4 percentage of participants Interval 7.74 to 34.33	26.3 percentage of participants Interval 9.15 to 51.2	16.7 percentage of participants Interval 3.58 to 41.42	33.3 percentage of participants Interval 7.49 to 70.07	20.0 percentage of participants Interval 5.73 to 43.66	15.4 percentage of participants Interval 1.92 to 45.45	29.4 percentage of participants Interval 15.1 to 47.48	53.8 percentage of participants Interval 37.18 to 69.91
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain B/Victoria lineage	13.2 percentage of participants Interval 4.41 to 28.09	5.3 percentage of participants Interval 0.13 to 26.03	11.1 percentage of participants Interval 1.38 to 34.71	11.1 percentage of participants Interval 0.28 to 48.25	15.0 percentage of participants Interval 3.21 to 37.89	7.7 percentage of participants Interval 0.19 to 36.03	11.8 percentage of participants Interval 3.3 to 27.45	46.2 percentage of participants Interval 30.09 to 62.82

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: Participants in PP Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=38 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=20 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=34 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=39 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain H1N1	89.5 percentage of participants Interval 75.2 to 97.06	78.9 percentage of participants Interval 54.43 to 93.95	100 percentage of participants Interval 81.47 to 100.0	100 percentage of participants Interval 66.37 to 100.0	80.0 percentage of participants Interval 56.34 to 94.27	84.6 percentage of participants Interval 54.55 to 98.08	88.2 percentage of participants Interval 72.55 to 96.7	92.3 percentage of participants Interval 79.13 to 98.38
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain H3N2	73.7 percentage of participants Interval 56.9 to 86.6	57.9 percentage of participants Interval 33.5 to 79.75	72.2 percentage of participants Interval 46.52 to 90.31	66.7 percentage of participants Interval 29.93 to 92.51	55.0 percentage of participants Interval 31.53 to 76.94	53.8 percentage of participants Interval 25.13 to 80.78	79.4 percentage of participants Interval 62.1 to 91.3	89.7 percentage of participants Interval 75.78 to 97.13
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain B/Victoria lineage	71.1 percentage of participants Interval 54.1 to 84.58	42.1 percentage of participants Interval 20.25 to 66.5	61.1 percentage of participants Interval 35.75 to 82.7	77.8 percentage of participants Interval 39.99 to 97.19	45.0 percentage of participants Interval 23.06 to 68.47	61.5 percentage of participants Interval 31.58 to 86.14	64.7 percentage of participants Interval 46.49 to 80.25	76.9 percentage of participants Interval 60.67 to 88.87

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Day 28

Population: Participants in PP Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=38 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=20 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=34 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=39 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain H1N1	3.6764 ratio Interval 2.5186 to 5.3663	2.4044 ratio Interval 1.4056 to 4.113	4.6104 ratio Interval 2.6534 to 8.0105	7.7661 ratio Interval 3.5725 to 16.8825	2.2511 ratio Interval 1.3376 to 3.7885	4.1198 ratio Interval 2.1579 to 7.8655	2.7513 ratio Interval 1.8449 to 4.1028	5.0566 ratio Interval 3.4783 to 7.351
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain H3N2	2.6710 ratio Interval 1.7985 to 3.9667	2.2043 ratio Interval 1.2571 to 3.8651	2.8906 ratio Interval 1.6272 to 5.135	2.3315 ratio Interval 1.0348 to 5.2531	1.7248 ratio Interval 0.9969 to 2.9842	1.6487 ratio Interval 0.8391 to 3.2397	3.2113 ratio Interval 2.1092 to 4.8895	4.5766 ratio Interval 3.0985 to 6.7598
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain B/Victoria lineage	2.2441 ratio Interval 1.7023 to 2.9582	1.3040 ratio Interval 0.8847 to 1.9221	1.7604 ratio Interval 1.1839 to 2.6177	1.8557 ratio Interval 1.0562 to 3.2605	1.6675 ratio Interval 1.1438 to 2.431	1.4026 ratio Interval 0.8791 to 2.2377	1.7975 ratio Interval 1.3458 to 2.4008	3.5002 ratio Interval 2.6662 to 4.595

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Day 28

Population: Participants in PP Set with available data were analyzed.

The GMTs in each treatment group were measured using an MN assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=38 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=21 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=36 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=38 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain H1N1: Day 0	127.4353 titers Interval 77.4879 to 209.5779	137.0522 titers Interval 66.5218 to 282.363	195.2871 titers Interval 96.6328 to 394.6597	216.6401 titers Interval 73.2581 to 640.6514	122.6834 titers Interval 62.8276 to 239.5636	93.8593 titers Interval 40.0947 to 219.7194	141.0830 titers Interval 84.6249 to 235.2074	89.1100 titers Interval 54.184 to 146.5489
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain H1N1: Day 28	663.8670 titers Interval 406.4999 to 1084.1807	495.8821 titers Interval 247.8117 to 992.2818	887.6906 titers Interval 435.2611 to 1810.395	1956.7218 titers Interval 714.1894 to 5360.9873	532.9893 titers Interval 266.3556 to 1066.5349	693.3781 titers Interval 299.7565 to 1603.8791	434.8282 titers Interval 258.8898 to 730.3325	754.0606 titers Interval 461.7274 to 1231.4786
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain H3N2: Day 0	96.9336 titers Interval 72.6176 to 129.3919	84.7454 titers Interval 55.7015 to 128.9334	123.9489 titers Interval 82.3861 to 186.4795	107.6687 titers Interval 54.9339 to 211.0273	65.5761 titers Interval 44.4647 to 96.711	129.3964 titers Interval 78.9714 to 212.0188	98.8487 titers Interval 73.4685 to 132.9967	100.5515 titers Interval 75.3279 to 134.2212
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain H3N2: Day 28	205.2176 titers Interval 159.9359 to 263.3195	186.1487 titers Interval 130.8414 to 264.8346	198.6618 titers Interval 139.6367 to 282.6371	332.5998 titers Interval 207.8591 to 532.2001	188.4193 titers Interval 136.3382 to 260.3952	196.9789 titers Interval 126.1081 to 307.6778	216.0005 titers Interval 166.9689 to 279.4306	273.0912 titers Interval 215.1708 to 346.6029
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain B/Yamagata lineage: Day 0	18.9617 titers Interval 13.164 to 27.3129	10.7232 titers Interval 6.2408 to 18.4248	16.3090 titers Interval 9.8086 to 27.1173	17.5404 titers Interval 8.3588 to 36.8073	10.8996 titers Interval 6.8206 to 17.4178	10.2622 titers Interval 5.7375 to 18.3551	20.6308 titers Interval 14.3227 to 29.7171	22.3655 titers Interval 15.8453 to 31.5688
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain B/Yamagata lineage: Day 28	38.0649 titers Interval 26.8412 to 53.9819	15.4893 titers Interval 9.5295 to 25.1765	25.7962 titers Interval 15.8706 to 41.9293	34.2802 titers Interval 18.3102 to 64.1793	21.5952 titers Interval 13.8604 to 33.6464	15.7214 titers Interval 9.33 to 26.4911	30.5144 titers Interval 21.2453 to 43.8276	64.2153 titers Interval 45.5476 to 90.534
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain B/Victoria lineage: Day 0	34.8450 titers Interval 23.3979 to 51.8924	15.8462 titers Interval 8.8842 to 28.2642	25.7760 titers Interval 14.676 to 45.2712	25.9287 titers Interval 10.8847 to 61.7654	15.3550 titers Interval 8.9863 to 26.2372	29.8305 titers Interval 15.0989 to 58.9354	22.2014 titers Interval 14.7461 to 33.426	14.2585 titers Interval 9.5743 to 21.2342
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain B/Victoria lineage: Day 28	70.2059 titers Interval 44.6561 to 110.374	36.2627 titers Interval 18.9559 to 69.3709	42.3874 titers Interval 22.1575 to 81.0874	104.7367 titers Interval 41.8496 to 262.1236	45.4444 titers Interval 24.17 to 85.4443	75.8887 titers Interval 35.3738 to 162.8065	33.2720 titers Interval 20.7539 to 53.3406	64.2444 titers Interval 41.1098 to 100.3983

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: Participants in PP Set with available data were analyzed.

Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable MN titer (i.e. \<10) pre-vaccination (Day 0) to an MN titer of ≥40 on Day 28 was measured using an MN assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=38 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=8 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=33 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=37 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain H1N1	55.3 percentage of participants Interval 38.3 to 71.38	33.3 percentage of participants Interval 13.34 to 59.01	38.9 percentage of participants Interval 17.3 to 64.25	50.0 percentage of participants Interval 15.7 to 84.3	42.1 percentage of participants Interval 20.25 to 66.5	61.5 percentage of participants Interval 31.58 to 86.14	33.3 percentage of participants Interval 17.96 to 51.83	59.5 percentage of participants Interval 42.1 to 75.25
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain H3N2	15.6 percentage of participants Interval 5.28 to 32.79	26.7 percentage of participants Interval 7.79 to 55.1	12.5 percentage of participants Interval 1.55 to 38.35	42.9 percentage of participants Interval 9.9 to 81.59	42.1 percentage of participants Interval 20.25 to 66.5	10.0 percentage of participants Interval 0.25 to 44.5	17.2 percentage of participants Interval 5.85 to 35.77	35.3 percentage of participants Interval 19.75 to 53.51
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain B/Yamagata lineage	17.2 percentage of participants Interval 5.85 to 35.77	7.1 percentage of participants Interval 0.18 to 33.87	20.0 percentage of participants Interval 4.33 to 48.09	12.5 percentage of participants Interval 0.32 to 52.65	22.2 percentage of participants Interval 6.41 to 47.64	0 percentage of participants Interval 0.0 to 24.71	3.8 percentage of participants Interval 0.1 to 19.64	34.5 percentage of participants Interval 17.94 to 54.33
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain B/Victoria lineage	18.9 percentage of participants Interval 7.96 to 35.16	29.4 percentage of participants Interval 10.31 to 55.96	5.6 percentage of participants Interval 0.14 to 27.29	25.0 percentage of participants Interval 3.19 to 65.09	26.3 percentage of participants Interval 9.15 to 51.2	30.8 percentage of participants Interval 9.09 to 61.43	15.2 percentage of participants Interval 5.11 to 31.9	43.2 percentage of participants Interval 27.1 to 60.51

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Day 28

Population: Participants in PP Set with available data were analyzed.

GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an MN assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).

Outcome measures

Outcome measures
Measure	QVLP30+Full AS03 n=38 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Full AS03 n=18 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=8 Participants Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=19 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 Participants Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=33 Participants Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=37 Participants Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain H1N1	5.2592 ratio Interval 3.4061 to 8.1206	4.0415 ratio Interval 2.1497 to 7.5982	6.0914 ratio Interval 3.2359 to 11.4669	12.7121 ratio Interval 4.9188 to 32.8531	4.0654 ratio Interval 2.199 to 7.5158	6.3495 ratio Interval 3.0183 to 13.3571	3.4096 ratio Interval 2.1392 to 5.4344	6.5345 ratio Interval 4.201 to 10.1641
GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain H3N2	2.1798 ratio Interval 1.7414 to 2.7287	2.0133 ratio Interval 1.4499 to 2.7956	1.8781 ratio Interval 1.3659 to 2.5824	2.7393 ratio Interval 1.6952 to 4.4264	2.1935 ratio Interval 1.6353 to 2.9422	1.8735 ratio Interval 1.2531 to 2.801	2.1377 ratio Interval 1.6879 to 2.7074	2.8084 ratio Interval 2.259 to 3.4914
GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain B/Yamagata lineage	2.3239 ratio Interval 1.7552 to 3.0767	1.3802 ratio Interval 0.9177 to 2.0758	1.7366 ratio Interval 1.1767 to 2.5629	1.8812 ratio Interval 1.1036 to 3.2068	1.7651 ratio Interval 1.2341 to 2.5247	1.3086 ratio Interval 0.8592 to 1.993	1.8310 ratio Interval 1.3613 to 2.4628	3.5437 ratio Interval 2.6727 to 4.6986
GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain B/Victoria lineage	2.4424 ratio Interval 1.7 to 3.5091	2.3549 ratio Interval 1.3853 to 4.0032	1.7152 ratio Interval 1.0254 to 2.8691	4.4083 ratio Interval 2.0388 to 9.532	2.4501 ratio Interval 1.4844 to 4.044	2.8024 ratio Interval 1.5286 to 5.1377	1.5535 ratio Interval 1.0629 to 2.2706	3.8216 ratio Interval 2.6602 to 5.4898

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. \<10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Day 28

Population: The analysis were not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

The GMTs in each treatment group were measured using an HI assay for the heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. \<10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the following heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the following heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the heterologous strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

The GMTs in each treatment group were measured using an MN assay for the following homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable MN titer (i.e. \<10) pre-vaccination (Day 0) to an MN titer of ≥40 on Day 28 was measured using an MN assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an MN assay for the strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 minutes post-vaccination

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 minutes post-vaccination

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 minutes post-vaccination

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. A related AE is an event where the investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related", or "Definitely Related". If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 7

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 7

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) up to Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. A related AE was an event where the Investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related", or "Definitely Related". It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases had to be reported. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

The number of participants in each treatment group with an occurrence of death was assessed. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination)

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as "clinically significant" or "not clinically significant" by the site investigator. It was planned that the endpoint would be analyzed if \>25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 3

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 28

Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.

Outcome measures

Outcome data not reported

Adverse Events

QVLP15+Full AS03

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

QVLP15+Half AS03

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

QVLP30+Full AS03

Serious events: 6 serious events

Other events: 19 other events

Deaths: 1 deaths

QVLP30+Half AS03

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

QVLP45+Full AS03

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

QVLP45+Half AS03

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

QVLP30 Unadjuvanted

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Fluzone HD Quad

Serious events: 5 serious events

Other events: 16 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	QVLP15+Full AS03 n=19 participants at risk Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 participants at risk Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30+Full AS03 n=42 participants at risk Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 participants at risk Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 participants at risk Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 participants at risk Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 participants at risk Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 participants at risk Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Infections and infestations COVID-19	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations COVID-19 pneumonia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.3% 1/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Diverticulitis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Pneumonia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.1% 1/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Pneumonia aspiration	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Urinary tract infection	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Urosepsis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.1% 1/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Psychiatric disorders Alcohol abuse	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Psychiatric disorders Confusional state	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Nervous system disorders Syncope	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Ear and labyrinth disorders Vertigo	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Vascular disorders Aortic stenosis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.1% 1/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Diarrhoea	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Fall	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.1% 1/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.

Other adverse events

Other adverse events
Measure	QVLP15+Full AS03 n=19 participants at risk Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP15+Half AS03 n=9 participants at risk Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30+Full AS03 n=42 participants at risk Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).	QVLP30+Half AS03 n=19 participants at risk Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Full AS03 n=23 participants at risk Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP45+Half AS03 n=13 participants at risk Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).	QVLP30 Unadjuvanted n=41 participants at risk Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).	Fluzone HD Quad n=43 participants at risk Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
General disorders Oedema peripheral	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Investigations Blood pressure increased	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	22.2% 2/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Asymptomatic COVID-19	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Bronchitis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.7% 2/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations COVID-19	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.3% 1/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	9.8% 4/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations COVID-19 pneumonia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.3% 1/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Cellulitis	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	7.7% 1/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Bone contusion	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	7.7% 1/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Concussion	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Clostridium difficile colitis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Coccidioidomycosis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Cystitis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Escherichia urinary tract infection	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Gastroenteritis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Herpes zoster	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.3% 1/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Infection parasitic	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Influenza	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Pneumonia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Respiratory tract infection	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Sinusitis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Tooth abscess	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Upper respiratory tract infection	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Urinary tract infection	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.9% 5/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.9% 2/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	7.7% 1/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Blood and lymphatic system disorders Anaemia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.1% 1/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.1% 1/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.1% 1/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.8% 2/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.1% 1/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Metabolism and nutrition disorders Type 2 diabetes mellitus	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Psychiatric disorders Anxiety	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.1% 1/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Psychiatric disorders Depression	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Psychiatric disorders Nightmare	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Nervous system disorders Cervical radiculopathy	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Nervous system disorders Headache	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Nervous system disorders Neuropathy peripheral	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Nervous system disorders Presyncope	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Eye disorders Cataract	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.8% 2/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Ear and labyrinth disorders Hypoacusis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Ear and labyrinth disorders Tinnitus	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Cardiac disorders Angina pectoris	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.3% 1/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Cardiac disorders Atrial fibrillation	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Cardiac disorders Coronary artery disease	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.8% 2/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Vascular disorders Deep vein thrombosis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Vascular disorders Hypertension	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Respiratory, thoracic and mediastinal disorders Allergic sinusitis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.3% 1/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.7% 2/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.9% 2/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.3% 1/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Diarrhoea	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Diverticulum	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	7.7% 1/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Dyspepsia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	9.5% 4/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.3% 1/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Gingival recession	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Haematochezia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	7.7% 1/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Haemorrhoids	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	7.7% 1/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Hiatus hernia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Large intestine polyp	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	7.7% 1/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Retching	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Gastrointestinal disorders Toothache	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Skin and subcutaneous tissue disorders Rash pruritic	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	7.7% 1/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.8% 2/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.1% 1/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.3% 1/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.1% 1/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	7.7% 1/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Renal and urinary disorders Acute kidney injury	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Renal and urinary disorders Renal cyst	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.3% 1/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Renal and urinary disorders Urinary bladder polyp	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	11.1% 1/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Renal and urinary disorders Urinary incontinence	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Reproductive system and breast disorders Perineal cyst	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Reproductive system and breast disorders Sexual dysfunction	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
General disorders Fatigue	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
General disorders Injection site pruritus	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Contusion	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	7.7% 1/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Fall	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	7.7% 1/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.4% 1/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.7% 2/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Thermal burn	5.3% 1/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	4.3% 1/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/9 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/42 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/19 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/23 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/13 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	0.00% 0/41 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.	2.3% 1/43 • Day 0 (post-vaccination) to Day 365 (end of study) SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.

Additional Information

Medical Director

Medicago

Phone: +1 418-658-9393

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Investigator understands that the information in the protocol is confidential and should not be disclosed, other than to those directly involved in the execution or the ethical review of the study, without prior written authorization from the Sponsor. It is, however, permissible to discuss information contained in the protocol with a participant in order to obtain consent once Institutional Review Board (IRB) approval is obtained.
Publication restrictions are in place

Restriction type: OTHER