Trial Outcomes & Findings for Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children. (NCT NCT01964989)

NCT ID: NCT01964989

Last Updated: 2023-03-27

Results Overview

Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to \<72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 10644 participants
• Primary outcome timeframe: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
• Results posted on: 2023-03-27

Participant Flow

Subjects were enrolled from 146 sites in 9 countries.

All enrolled subjects were included in the trial. Non-naive participants received 1 dose of vaccine on Day 1 only. Naive participants received 2 doses of vaccine, the first dose on Day 1 and the second dose on Day 29.

Participant milestones

Measure	aQIV (≥6 to <72 Months) Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) Subjects ≥6 to \<72 months of age who received TIV/QIV
Overall Study STARTED	5352	5292
Overall Study COMPLETED	4568	4545
Overall Study NOT COMPLETED	784	747

Reasons for withdrawal

Measure	aQIV (≥6 to <72 Months) Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) Subjects ≥6 to \<72 months of age who received TIV/QIV
Overall Study Protocol Violation	3	4
Overall Study Administrative Reason	103	95
Overall Study Adverse Event	0	1
Overall Study Death	1	3
Overall Study Withdrawal by Subject	156	160
Overall Study Lost to Follow-up	254	232
Overall Study Other	267	252

Baseline Characteristics

Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

Baseline characteristics by cohort

Measure	aQIV (≥6 to <72 Months) n=5352 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=5292 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	Total n=10644 Participants Total of all reporting groups
Age, Continuous	38.4 months STANDARD_DEVIATION 18.43 • n=5 Participants	38 months STANDARD_DEVIATION 18.40 • n=7 Participants	38.2 months STANDARD_DEVIATION 18.42 • n=5 Participants
Sex: Female, Male Female	2643 Participants n=5 Participants	2590 Participants n=7 Participants	5233 Participants n=5 Participants
Sex: Female, Male Male	2709 Participants n=5 Participants	2702 Participants n=7 Participants	5411 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	664 Participants n=5 Participants	632 Participants n=7 Participants	1296 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4678 Participants n=5 Participants	4647 Participants n=7 Participants	9325 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) Asian	2348 Participants n=5 Participants	2361 Participants n=7 Participants	4709 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) Black or African American	711 Participants n=5 Participants	692 Participants n=7 Participants	1403 Participants n=5 Participants
Race (NIH/OMB) White	2153 Participants n=5 Participants	2091 Participants n=7 Participants	4244 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	116 Participants n=5 Participants	121 Participants n=7 Participants	237 Participants n=5 Participants
Naivety Status Vaccine Naive	3611 Participants n=5 Participants	3597 Participants n=7 Participants	7208 Participants n=5 Participants
Naivety Status Vaccine Non-Naive	1741 Participants n=5 Participants	1695 Participants n=7 Participants	3436 Participants n=5 Participants

PRIMARY outcome

Timeframe: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer

Population: The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis.

Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=5278 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=5193 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age Any strain	256 Number of cases	252 Number of cases	—	—	—	—	—	—
Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age A/H1N1	7 Number of cases	17 Number of cases	—	—	—	—	—	—
Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age A/H3N2	200 Number of cases	196 Number of cases	—	—	—	—	—	—
Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age B/Yamagata	36 Number of cases	36 Number of cases	—	—	—	—	—	—
Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age B/Victoria	14 Number of cases	9 Number of cases	—	—	—	—	—	—

SECONDARY outcome

Timeframe: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer

Population: The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis.

Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=1299 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=1339 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) n=2484 Participants Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) n=2471 Participants Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) n=2794 Participants Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) n=2722 Participants Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. Any Strain	55 Number of cases	79 Number of cases	115 Number of cases	119 Number of cases	141 Number of cases	133 Number of cases	—	—
Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. A/H1N1	2 Number of cases	5 Number of cases	5 Number of cases	8 Number of cases	2 Number of cases	9 Number of cases	—	—
Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. A/H3N2	44 Number of cases	66 Number of cases	92 Number of cases	99 Number of cases	108 Number of cases	97 Number of cases	—	—
Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. B/Yamagata	5 Number of cases	9 Number of cases	13 Number of cases	12 Number of cases	23 Number of cases	24 Number of cases	—	—
Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. B/Victoria	4 Number of cases	0 Number of cases	5 Number of cases	1 Number of cases	9 Number of cases	8 Number of cases	—	—

SECONDARY outcome

Timeframe: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer

Population: The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis.

Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=5278 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=5193 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) n=1299 Participants Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) n=1339 Participants Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) n=2484 Participants Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) n=2471 Participants Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) n=2794 Participants Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) n=2722 Participants Subjects ≥36 to \<72 months of age who received TIV/QIV
Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age Unmatched strain	65 Number of cases	62 Number of cases	12 Number of cases	14 Number of cases	29 Number of cases	23 Number of cases	36 Number of cases	39 Number of cases
Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age Any strain	140 Number of cases	146 Number of cases	31 Number of cases	48 Number of cases	64 Number of cases	68 Number of cases	76 Number of cases	78 Number of cases
Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age Matched strain	74 Number of cases	80 Number of cases	19 Number of cases	32 Number of cases	35 Number of cases	42 Number of cases	39 Number of cases	38 Number of cases

SECONDARY outcome

Timeframe: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer

Population: The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis.

Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to <72 months of age with RT-PCR confirmed and culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer, in healthy subjects and subjects at risk of influenza related complications. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=5278 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=5193 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications Healthy RT-PCR	244 Number of cases	233 Number of cases	—	—	—	—	—	—
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications High Risk RT-PCR	12 Number of cases	19 Number of cases	—	—	—	—	—	—
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications Healthy Culture-confirmed	130 Number of cases	136 Number of cases	—	—	—	—	—	—
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications High Risk Culture-confirmed	10 Number of cases	10 Number of cases	—	—	—	—	—	—

SECONDARY outcome

Timeframe: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer

Population: The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis.

Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=5278 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=5193 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately Vaccine Naive RT-PCR	160 Number of cases	170 Number of cases	—	—	—	—	—	—
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately Vaccine Non-naive RT-PCR	96 Number of cases	82 Number of cases	—	—	—	—	—	—
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately Vaccine Naive Culture-confirmed	80 Number of cases	101 Number of cases	—	—	—	—	—	—
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately Vaccine Non-naive Culture-confirmed	60 Number of cases	45 Number of cases	—	—	—	—	—	—

SECONDARY outcome

Timeframe: ≥7 days and at ≥14 days after first vaccination up to day of second vaccination

Population: Full Analysis Set Early Efficacy: All subjects in the Enrolled Set who actually received a study vaccination and were evaluated for efficacy at least 7 days after the last vaccination.

Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naive subjects ≥6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≥14 days after the first vaccination up to the day of the second vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=3559 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=3535 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only ≥7 days after first and up to second vaccination	16 Number of cases	35 Number of cases	—	—	—	—	—	—
Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only ≥14 days after first and up to second vaccination	8 Number of cases	27 Number of cases	—	—	—	—	—	—

SECONDARY outcome

Timeframe: ≥7 days and ≤21 days after the last vaccination

Population: Full Analysis Set Early Efficacy: All subjects in the Enrolled Set who actually received a study vaccination and were evaluated for efficacy at least 7 days after the last vaccination.

Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naïve subjects ≥6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≤21 after the last vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=5286 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=5208 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age Occurring at ≥7 Days and ≤21 Days After Last Vaccination, in All Subjects.	4 Number of cases	15 Number of cases	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects

Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.

Pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination) and Day 181/209 (ie, 180 days after last vaccination) assessments; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=1481 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=1405 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age A/H1N1, Day 1	40.08 titer Interval 32.3 to 49.7	39.49 titer Interval 31.8 to 49.1	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age A/H1N1, D22/50	996.40 titer Interval 888.4 to 1117.6	522.50 titer Interval 465.3 to 586.7	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age A/H1N1, D181/209	351.59 titer Interval 311.2 to 397.2	189.43 titer Interval 167.4 to 214.3	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age A/H3N2, Day 1	72.96 titer Interval 58.1 to 91.6	70.38 titer Interval 55.9 to 88.5	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age A/H3N2, D22/50	1153.4 titer Interval 1035.4 to 1284.9	674.01 titer Interval 604.4 to 751.6	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age A/H3N2, D181/209	458.07 titer Interval 403.0 to 520.6	290.88 titer Interval 255.5 to 331.1	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age B/Yamagata, Day 1	10.17 titer Interval 9.0 to 11.5	10.12 titer Interval 9.0 to 11.4	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age B/Yamagata, Day 22/50	198.89 titer Interval 173.1 to 228.5	90.68 titer Interval 78.8 to 104.3	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age B/Yamagata, Day 181/209	48.65 titer Interval 42.9 to 55.2	26.22 titer Interval 23.1 to 29.8	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age B/Victoria, Day 1	10.45 titer Interval 9.6 to 11.4	10.36 titer Interval 9.5 to 11.3	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age B/Victoria, Day 22/50	315.52 titer Interval 287.5 to 346.3	138.82 titer Interval 125.2 to 153.9	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age B/Victoria, Day 181/209	65.78 titer Interval 59.7 to 72.4	36.46 titer Interval 32.9 to 40.4	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29 and Day 50

Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.

GMTs for vaccine naïve subjects are provided by strain for Day 29 and Day 50; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=922 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=866 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age B/Yamagata, Day 50	224.77 titer Interval 188.6 to 267.9	86.91 titer Interval 72.8 to 103.7	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age B/Victoria, Day 29	81.98 titer Interval 69.9 to 96.2	33.44 titer Interval 27.9 to 40.1	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age B/Victoria, Day 50	418.16 titer Interval 376.7 to 464.2	160.35 titer Interval 142.0 to 181.0	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age A/H1N1, Day 29	483.55 titer Interval 395.0 to 591.9	172.92 titer Interval 141.2 to 211.8	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age A/H1N1, Day 50	1065.19 titer Interval 916.0 to 1238.7	553.57 titer Interval 475.5 to 644.4	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age A/H3N2, Day 29	742.82 titer Interval 622.8 to 886.0	342.90 titer Interval 287.4 to 409.1	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age A/H3N2, Day 50	1275.18 titer Interval 1108.8 to 1466.6	720.44 titer Interval 626.0 to 829.1	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age B/Yamagata, Day 29	62.73 titer Interval 51.1 to 77.0	31.40 titer Interval 25.6 to 38.6	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.

HI GMT was assessed on Day 1 and Day 50 for vaccine naïve healthy vs high risk subjects; and HI GMT were assessed on Day 1 and Day 22 for vaccine non-naïve healthy vs high risk subjects; pooled GMT values across both naïve and non-naïve subjects are provided for Day 22/50 (ie, 21 days after last vaccination) assessments.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=1208 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=273 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) n=1171 Participants Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) n=234 Participants Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age A/H1N1, Day 22/50	988.65 titer Interval 863.68 to 1131.6	906.86 titer Interval 777.8 to 1057.3	563.87 titer Interval 471.8 to 674.0	533.71 titer Interval 436.8 to 652.2	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age A/H3N2, Day 1	76.80 titer Interval 56.3 to 104.8	104.07 titer Interval 73.0 to 148.3	55.08 titer Interval 40.1 to 75.8	59.89 titer Interval 41.7 to 85.9	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age A/H3N2, Day 22/50	1159.57 titer Interval 1017.2 to 1321.9	1179.55 titer Interval 1015.7 to 1369.9	693.27 titer Interval 589.4 to 815.4	680.08 titer Interval 566.6 to 816.2	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age B/YAM, Day 1	9.95 titer Interval 8.5 to 11.7	11.72 titer Interval 9.7 to 14.1	8.76 titer Interval 7.4 to 10.4	10.18 titer Interval 8.4 to 12.4	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age B/YAM, Day 22/50	203.14 titer Interval 169.6 to 243.4	198.58 titer Interval 161.7 to 243.9	94.76 titer Interval 77.6 to 115.8	89.59 titer Interval 71.5 to 112.1	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age A/H1N1, Day 1	35.34 titer Interval 26.4 to 47.2	48.29 titer Interval 34.7 to 67.2	31.64 titer Interval 23.3 to 42.9	45.12 titer Interval 31.9 to 63.8	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age B/VIC, Day 1	10.87 titer Interval 9.1 to 12.9	10.51 titer Interval 8.6 to 12.8	8.17 titer Interval 6.6 to 10.1	9.03 titer Interval 7.1 to 11.5	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age B/VIC, Day 22/50	323.42 titer Interval 264.0 to 396.2	298.20 titer Interval 236.7 to 375.7	151.17 titer Interval 120.3 to 189.9	138.94 titer Interval 107.3 to 179.9	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects

Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.

The fold-increase in HI antibodies in response to vaccination was assessed as the GMR between all post-vaccination titers (ie, Day 29, 50, 209 for vaccine naïve subjects; Day 22, 181 for vaccine non-naïve subjects) and the baseline (Day 1) titer. Assessed GMRs thus correspond to Day 29/Day 1, Day 50/Day 1, and Day 209/Day 1 for vaccine naïve subjects and Day 22/Day 1 and Day 181/Day 1 for vaccine non-naïve subjects. Pooled GMR values across both naïve and non-naïve subjects are provided for Day (22/50)/Day 1 (ie, 21 days after last vaccination) and Day (181/209)/Day 1 (ie, 180 days after last vaccination); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=1481 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=1405 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age A/H1N1, Day 22/50:Day 1	24.96 ratio Interval 22.3 to 28.0	13.09 ratio Interval 11.7 to 14.7	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age A/H3N2, Day 22/50:Day 1	21.68 ratio Interval 19.5 to 24.1	12.67 ratio Interval 11.4 to 14.1	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age B/Yamagata, Day 22/50:Day 1	18.08 ratio Interval 15.7 to 20.8	8.25 ratio Interval 7.2 to 9.5	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age B/Victoria, Day 22/50/Day 1	29.70 ratio Interval 26.9 to 32.7	13.28 ratio Interval 12.0 to 14.7	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age A/H1N1, Day 181/209:Day 1	8.57 ratio Interval 7.6 to 9.7	4.62 ratio Interval 4.1 to 5.2	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age A/H3N2, Day 181/209:Day 1	8.64 ratio Interval 7.6 to 9.8	5.49 ratio Interval 4.8 to 6.2	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age B/Yamagata Day 181/209:Day 1	4.38 ratio Interval 3.9 to 5.0	2.36 ratio Interval 2.1 to 2.7	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age B/Victoria, Day 181/209/Day 1	6.28 ratio Interval 5.7 to 6.9	3.56 ratio Interval 3.3 to 3.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.

SC rates were assessed on Day 1 and Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 1 and Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strain: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine.

comparison analysis (N=745 for aQIV, N=738 for comparator).

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=1481 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=1405 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age A/H1N1	81.9 percentage of subjects Interval 79.7 to 83.9	73.7 percentage of subjects Interval 71.2 to 76.1	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age A/H3N2	78.4 percentage of subjects Interval 76.1 to 80.6	73.2 percentage of subjects Interval 70.7 to 75.6	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age B/Yamagata	86.0 percentage of subjects Interval 84.1 to 87.8	64.7 percentage of subjects Interval 62.1 to 67.3	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age B/Victoria	91.0 percentage of subjects Interval 88.8 to 93.0	77.4 percentage of subjects Interval 74.2 to 80.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and 180 days after the last vaccination (Day 209 for vaccine naive subjects; Day 181 for vaccine non-naïve subjects)

Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.

Antibody response was assessed as the percentage of subjects with HI titer of ≥1:40 at 180 days after last vaccination (ie, Day 209 for vaccine naïve subjects and Day 181 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=1481 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=1405 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age A/H1N1	97.1 percentage of subjects Interval 96.0 to 98.0	85.6 percentage of subjects Interval 83.6 to 87.5	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age A/H3N2	98.1 percentage of subjects Interval 97.1 to 98.7	90.2 percentage of subjects Interval 88.4 to 91.8	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age B/Yamagata	66.6 percentage of subjects Interval 63.9 to 69.2	44.7 percentage of subjects Interval 41.9 to 47.5	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age B/Victoria	74.0 percentage of subjects Interval 70.6 to 77.2	53.1 percentage of subjects Interval 49.4 to 56.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.

Antibody response was assessed as the percentage of subjects and differences of percentage of subjects with HI titers of ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=1481 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=1405 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:110, A/H1N1, Day 22/50	97.3 percentage of subjects Interval 96.3 to 98.1	89.5 percentage of subjects Interval 87.7 to 91.1	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:151, A/H1N1, Day 22/50	96.5 percentage of subjects Interval 95.4 to 97.5	86.8 percentage of subjects Interval 84.8 to 88.6	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:215, A/H1N1, Day 22/50	94.0 percentage of subjects Interval 92.6 to 95.2	77.9 percentage of subjects Interval 75.5 to 80.1	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:330, A/H1N1, Day 22/50	83.8 percentage of subjects Interval 81.8 to 85.8	60.7 percentage of subjects Interval 58.0 to 63.4	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:629, A/H1N1, Day 22/50	76.2 percentage of subjects Interval 73.9 to 78.5	52.1 percentage of subjects Interval 49.4 to 54.8	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:110, A/H3N2, Day 22/50	99.0 percentage of subjects Interval 98.3 to 99.4	93.0 percentage of subjects Interval 91.5 to 94.4	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:151, A/H3N2, Day 22/50	98.4 percentage of subjects Interval 97.6 to 99.0	90.6 percentage of subjects Interval 88.9 to 92.1	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:215, A/H3N2, Day 22/50	96.5 percentage of subjects Interval 95.4 to 97.4	84.8 percentage of subjects Interval 82.7 to 86.7	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:330, A/H3N2, Day 22/50	89.4 percentage of subjects Interval 87.7 to 91.0	70.4 percentage of subjects Interval 67.8 to 72.9	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:629, A/H3N2, Day 22/50	84.2 percentage of subjects Interval 82.2 to 86.1	63.1 percentage of subjects Interval 60.4 to 65.7	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:110, B/YAM, Day 22/50	69.4 percentage of subjects Interval 66.9 to 71.8	40.6 percentage of subjects Interval 38.0 to 43.3	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:151, B/YAM, Day 22/50	60.7 percentage of subjects Interval 58.1 to 63.3	34.4 percentage of subjects Interval 31.9 to 37.1	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:215, B/YAM, Day 22/50	45.6 percentage of subjects Interval 42.9 to 48.3	23.8 percentage of subjects Interval 21.5 to 26.2	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:330, B/YAM, Day 22/50	24.9 percentage of subjects Interval 22.6 to 27.3	13.3 percentage of subjects Interval 11.5 to 15.3	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:629, B/YAM, Day 22/50	16.2 percentage of subjects Interval 14.3 to 18.3	9.4 percentage of subjects Interval 7.9 to 11.1	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:110, B/VIC, Day 22/50	78.3 percentage of subjects Interval 76.0 to 80.4	58.1 percentage of subjects Interval 54.5 to 61.7	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:151, B/VIC, Day 22/50	73.5 percentage of subjects Interval 71.1 to 75.8	52.4 percentage of subjects Interval 48.8 to 56.1	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:215, B/VIC, Day 22/50	62.3 percentage of subjects Interval 59.7 to 64.9	38.6 percentage of subjects Interval 35.1 to 42.2	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:330, B/VIC, Day 22/50	41.7 percentage of subjects Interval 39.1 to 44.4	21.8 percentage of subjects Interval 18.9 to 25.0	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age HI Titers ≥1:629, B/VIC, Day 22/50	31.9 percentage of subjects Interval 29.4 to 34.4	16.9 percentage of subjects Interval 14.3 to 19.8	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.

HI GMT was assessed 21 days after last vaccination (Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naive subjects) pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination); Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013-like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=297 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=295 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age A/H1N1, D22/50	7.46 titer Interval 6.3 to 8.9	6.52 titer Interval 5.5 to 7.8	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age A/H3N2, D22/50	576.84 titer Interval 407.4 to 816.7	297.70 titer Interval 209.0 to 424.1	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age B/Yamagata, Day 22/50	145.89 titer Interval 98.3 to 216.6	67.24 titer Interval 45.0 to 100.5	—	—	—	—	—	—
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age B/Victoria, Day 22/50	186.65 titer Interval 157.3 to 221.5	88.09 titer Interval 73.0 to 106.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.

SC rates were assessed on Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Heterologous strains include: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=297 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=295 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age A/H1N1	2.7 percentage of subjects Interval 1.2 to 5.3	1.4 percentage of subjects Interval 0.4 to 3.5	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age A/H3N2	86.0 percentage of subjects Interval 81.4 to 89.7	73.4 percentage of subjects Interval 68.0 to 78.4	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age B/Yamagata	82.7 percentage of subjects Interval 77.9 to 86.8	59.9 percentage of subjects Interval 54.1 to 65.6	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age B/Victoria	90.7 percentage of subjects Interval 84.6 to 95.0	75.8 percentage of subjects Interval 68.3 to 82.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.

Antibody persistence was assessed as the percentage of subjects with HI titer of ≥1:40 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects; Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=297 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=295 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age A/H1N1	6.1 percentage of subjects Interval 3.7 to 9.5	3.4 percentage of subjects Interval 1.7 to 6.2	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age A/H3N2	99.3 percentage of subjects Interval 97.5 to 99.9	93.1 percentage of subjects Interval 89.5 to 95.7	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age B/Yamagata	88.8 percentage of subjects Interval 84.6 to 92.2	68.2 percentage of subjects Interval 62.5 to 73.5	—	—	—	—	—	—
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age B/Victoria	95.7 percentage of subjects Interval 90.9 to 98.4	83.4 percentage of subjects Interval 76.7 to 88.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 days following each vaccination

Population: The Solicited Safety Set consisting of all subjects who received a study vaccination and had any assessment of local and systemic reactions and/or assessment of any use of analgesics/antipyretics was used for analysis.

Subjects ≥6 to <72 months of age reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with either aQIV or TIV/QIV.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=5138 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=5056 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs Others	1536 Participants	907 Participants	—	—	—	—	—	—
Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs Any	3748 Participants	3242 Participants	—	—	—	—	—	—
Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs Local	2651 Participants	2188 Participants	—	—	—	—	—	—
Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs Systemic	2714 Participants	2174 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 though Day 366 (vaccine non-naive)/Day 390 (vaccine naive)

Population: The Unsolicited Safety Set consisting of all subjects who received a study vaccination and had any AE assessments was used for analysis (ie, a subject did not have to have an AE to be included in this population).

Safety was assessed in terms of number of subjects ≥6 to <72 months of age reporting unsolicited reactions (Day 1 to Day 50 for vaccine naïve subjects and from Day 1 to Day 22 for vaccine non-naïve subjects); Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases,(NOCD), Adverse Events of Special Interests (AESI), AEs leading to withdrawal from the study or study vaccination after vaccination with either aQIV or TIV/QIV were collected up to 12 months after last vaccination.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=5243 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=5161 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs Any unsolicited AEs	3576 Participants	3543 Participants	—	—	—	—	—	—
Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs Possibly or probably related unsolicited AEs	686 Participants	533 Participants	—	—	—	—	—	—
Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs SAEs	234 Participants	230 Participants	—	—	—	—	—	—
Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs Possibly or probably related SAEs	6 Participants	1 Participants	—	—	—	—	—	—
Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs AEs with an outcome of death	1 Participants	3 Participants	—	—	—	—	—	—
Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs AEs leading to withdrawal	10 Participants	9 Participants	—	—	—	—	—	—
Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs AEs leading to NOCD	87 Participants	96 Participants	—	—	—	—	—	—
Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs AESIs	5 Participants	4 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: within a window of 14 days after influenza-like illness (ILI)-onset

Population: Full Analysis Set Health Economic Outcomes (Season 2): This analysis set includes all subjects in the Enrolled Set in Season 2 who: actually received a study vaccination and provided efficacy data and Health Economic data collected within 14 days of ILI-onset; and had a first-occurrence RT-PCR-confirmed influenza as included in the primary efficacy objective.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=255 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=250 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza	2.1 Number of days Standard Deviation 2.43	2.2 Number of days Standard Deviation 2.48	—	—	—	—	—	—

SECONDARY outcome

Timeframe: within a window of 14 days after ILI-onset

Population: Full Analysis Set Health Economic Outcomes (Season 2): This analysis set includes all subjects in the Enrolled Set in Season 2 who: actually received a study vaccination and provided efficacy data and Health Economic data collected within 14 days of ILI-onset; and had a first-occurrence RT-PCR-confirmed influenza as included in the primary efficacy objective.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=255 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=250 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza	1.0 Number of visits Standard Deviation 0.84	1.0 Number of visits Standard Deviation 0.74	—	—	—	—	—	—

SECONDARY outcome

Timeframe: within a window of 14 days after ILI-onset

Population: Full Analysis Set Health Economic Outcomes (Season 2): This analysis set includes all subjects in the Enrolled Set in Season 2 who: actually received a study vaccination and provided efficacy data and Health Economic data collected within 14 days of ILI-onset; and had a first-occurrence RT-PCR-confirmed influenza as included in the primary efficacy objective.

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=255 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=250 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza	1.0 Number of days Standard Deviation 1.68	1.0 Number of days Standard Deviation 1.88	—	—	—	—	—	—

SECONDARY outcome

Timeframe: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer

Population: Full Analysis Set Health Economic Outcomes (Season 2)

Outcome measures

Measure	aQIV (≥6 to <72 Months) n=255 Participants Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=250 Participants Subjects ≥6 to \<72 months of age who received TIV/QIV	aQIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received aQIV	TIV/QIV (≥6 to <36 Months) Subjects ≥6 to \<36 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV	aQIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received aQIV	TIV/QIV (≥36 to <72 Months) Subjects ≥36 to \<72 months of age who received TIV/QIV
Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. Any Strain	34 Number of cases	32 Number of cases	—	—	—	—	—	—
Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. A/H1N1	0 Number of cases	1 Number of cases	—	—	—	—	—	—
Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. A/H3N2	27 Number of cases	29 Number of cases	—	—	—	—	—	—
Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. B/Yamagata	4 Number of cases	2 Number of cases	—	—	—	—	—	—
Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. B/Victoria	3 Number of cases	0 Number of cases	—	—	—	—	—	—

Adverse Events

aQIV (≥6 to <72 Months)

Serious events: 234 serious events

Other events: 4627 other events

Deaths: 1 deaths

TIV/QIV (≥6 to <72 Months)

Serious events: 230 serious events

Other events: 4430 other events

Deaths: 3 deaths

Serious adverse events

Measure	aQIV (≥6 to <72 Months) n=5339 participants at risk；n=5243 participants at risk Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=5272 participants at risk；n=5161 participants at risk Subjects ≥6 to \<72 months of age who received TIV/QIV
Vascular disorders Kawasaki's disease	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ependymoma	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Immune system disorders Allergy to arthropod bite	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Immune system disorders Allergy to arthropod sting	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Immune system disorders Anaphylactic reaction	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Immune system disorders Hypersensitivity	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Immune system disorders Type I hypersensitivity	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
General disorders Influenza like illness	0.13% 7/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.16% 8/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
General disorders Pyrexia	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.12% 6/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
General disorders Systemic inflammatory response syndrome	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Accidental exposure to product	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Animal bite	0.46% 24/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.37% 19/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Animal scratch	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.06% 3/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Chemical burn of gastrointestinal tract	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Concussion	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Craniocerebral injury	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Exposure to toxic agent	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Femur fracture	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Forearm fracture	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Foreign body	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Gun shot wound	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Head injury	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Humerus fracture	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Injury	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Laceration	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Lower limb fracture	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Tongue injury	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Traumatic liver injury	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Vulvovaginal injury	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Cardiac disorders Cardiogenic shock	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Congenital, familial and genetic disorders Ankyloglossia congenital	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Congenital, familial and genetic disorders Dacryostenosis congenital	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Congenital, familial and genetic disorders Heart disease congenital	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Asthma	0.17% 9/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.21% 11/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.08% 4/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.06% 3/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.06% 3/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Wheezing	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Blood and lymphatic system disorders Leukocytosis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Blood and lymphatic system disorders Lymphadenitis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Nervous system disorders Autism	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Nervous system disorders Cerebral haemorrhage	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Nervous system disorders Encephalitis autoimmune	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Nervous system disorders Febrile convulsion	0.25% 13/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.14% 7/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Nervous system disorders Generalised tonic-clonic seizure	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Nervous system disorders Headache	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Nervous system disorders Loss of consciousness	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Nervous system disorders Partial seizures	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Nervous system disorders Seizure	0.06% 3/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Nervous system disorders Status epilepticus	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Abdominal pain	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Coeliac disease	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Constipation	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Crohn's disease	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Diarrhoea	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.10% 5/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Dysphagia	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Enteritis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Gastritis	0.10% 5/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.10% 5/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Gastrointestinal inflammation	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Inguinal hernia	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Intussusception	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Vomiting	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Renal and urinary disorders Hydronephrosis	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Renal and urinary disorders Post streptococcal glomerulonephritis	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Skin and subcutaneous tissue disorders Lichen sclerosus	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Skin and subcutaneous tissue disorders Papule	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Skin and subcutaneous tissue disorders Swelling face	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Skin and subcutaneous tissue disorders Urticaria	0.06% 3/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Product Issues Device malfunction	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Endocrine disorders Hyperaldosteronism	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Metabolism and nutrition disorders Dehydration	0.29% 15/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.21% 11/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Metabolism and nutrition disorders Hypokalaemia	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Metabolism and nutrition disorders Hypovolaemia	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Metabolism and nutrition disorders Metabolic acidosis	0.06% 3/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Metabolism and nutrition disorders Obesity	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Abdominal wall abscess	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Abscess jaw	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Acute sinusitis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Adenovirus infection	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Amoebiasis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Amoebic dysentery	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Atypical pneumonia	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Bacteraemia	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Bacterial sepsis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Brain abscess	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Breast abscess	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Bronchiolitis	0.13% 7/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Bronchitis	0.23% 12/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.25% 13/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Cellulitis	0.10% 5/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Cellulitis staphylococcal	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Cholera	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Corona virus infection	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Croup infectious	0.06% 3/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Dengue fever	0.17% 9/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.17% 9/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Diarrhoea infectious	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Exanthema subitum	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Folliculitis	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Gastritis viral	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Gastroenteritis	0.44% 23/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.45% 23/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.10% 5/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Gastroenteritis salmonella	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Gastroenteritis viral	0.06% 3/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.08% 4/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Groin abscess	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Hand-foot-and-mouth disease	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.08% 4/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Herpangina	0.10% 5/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Infectious mononucleosis	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Laryngitis viral	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Mastoiditis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Meningitis aseptic	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Meningitis bacterial	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Mycoplasma infection	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Nasopharyngitis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Oral herpes	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Otitis media	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Otitis media acute	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Periorbital cellulitis	0.04% 2/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Pharyngitis	0.08% 4/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.14% 7/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Pharyngotonsillitis	0.06% 3/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.06% 3/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Pneumonia	0.72% 38/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.54% 28/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Pneumonia adenoviral	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Pneumonia bacterial	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Pneumonia chlamydial	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Pneumonia mycoplasmal	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Pneumonia respiratory syncytial viral	0.06% 3/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Pneumonia viral	0.08% 4/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Pyelonephritis acute	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Respiratory syncytial virus infection	0.06% 3/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.06% 3/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Respiratory tract infection	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Rhinitis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Rhinovirus infection	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Sepsis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.06% 3/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Staphylococcal infection	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Staphylococcal scalded skin syndrome	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Staphylococcal sepsis	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Subcutaneous abscess	0.06% 3/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Tonsillitis	0.10% 5/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.06% 3/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Tooth abscess	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Typhoid fever	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.04% 2/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Upper respiratory tract infection	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.08% 4/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Urinary tract infection	0.06% 3/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.14% 7/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Viral diarrhoea	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Viral infection	0.08% 4/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.06% 3/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Viral pharyngitis	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Viral rash	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Viral sinusitis	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Wound infection	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Psychiatric disorders Irritability	0.00% 0/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.02% 1/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Psychiatric disorders Mental status changes	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
General disorders Injection site inflammation	0.02% 1/5243 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	0.00% 0/5161 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.

Other adverse events

Measure	aQIV (≥6 to <72 Months) n=5339 participants at risk；n=5243 participants at risk Subjects ≥6 to \<72 months of age who received aQIV	TIV/QIV (≥6 to <72 Months) n=5272 participants at risk；n=5161 participants at risk Subjects ≥6 to \<72 months of age who received TIV/QIV
Respiratory, thoracic and mediastinal disorders Cough	5.7% 305/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	5.9% 312/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.9% 206/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	4.3% 225/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Nervous system disorders Somnolence	25.6% 1366/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	21.0% 1107/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
General disorders Influenza like illness	50.4% 2690/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	50.5% 2664/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
General disorders Injection site pain	44.2% 2360/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	35.3% 1861/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
General disorders Injection site erythema	23.0% 1226/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	19.6% 1031/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
General disorders Pyrexia	22.1% 1178/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	14.8% 778/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
General disorders Injection site induration	15.1% 804/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	10.9% 576/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
General disorders Injection site haemorrhage	7.6% 407/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	7.1% 374/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
General disorders Chills	6.7% 356/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	4.0% 210/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Psychiatric disorders Irritability	27.0% 1441/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	22.8% 1204/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Psychiatric disorders Eating disorder	21.8% 1163/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	17.0% 898/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Diarrhoea	13.1% 701/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	12.8% 677/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Gastrointestinal disorders Vomiting	11.9% 634/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	9.8% 516/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Upper respiratory tract infection	13.5% 722/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	13.7% 724/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Nasopharyngitis	7.2% 387/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	6.9% 365/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Otitis media	7.0% 375/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	6.7% 352/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Pneumonia	4.1% 218/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	4.6% 241/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Rhinitis	4.0% 215/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	4.2% 221/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Bronchitis	3.5% 186/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	3.8% 201/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Infections and infestations Gastroenteritis	2.9% 156/5339 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.	2.6% 139/5272 • Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects. All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.

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