Trial Outcomes & Findings for Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older (NCT NCT04024228)

NCT ID: NCT04024228

Last Updated: 2025-09-12

Results Overview

GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1539 participants

Primary outcome timeframe

Day 28 post-vaccination

Results posted on

2025-09-12

Participant Flow

The study was conducted at 17 active centers in 6 countries. A total of 1539 participants were enrolled and randomized between 28 October 2019 to 15 November 2019.

A total of 1533 participants were vaccinated in the study.

Participant milestones

Participant milestones
Measure	Group 1: QIV-HD Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.	Group 2: QIV-SD Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), IM at Day 0.
Overall Study STARTED	774	765
Overall Study Vaccinated	772	761
Overall Study Full Analysis Set (FAS)	769	758
Overall Study COMPLETED	770	759
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: QIV-HD Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.	Group 2: QIV-SD Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), IM at Day 0.
Overall Study Adverse Event	1	0
Overall Study Protocol Deviation	0	2
Overall Study Withdrawal by Subject	3	4

Baseline Characteristics

Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: QIV-HD n=774 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=765 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.	Total n=1539 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	379 Participants n=93 Participants	381 Participants n=4 Participants	760 Participants n=27 Participants
Age, Categorical >=65 years	395 Participants n=93 Participants	384 Participants n=4 Participants	779 Participants n=27 Participants
Age, Continuous	66.6 years STANDARD_DEVIATION 5.82 • n=93 Participants	66.6 years STANDARD_DEVIATION 6.11 • n=4 Participants	66.6 years STANDARD_DEVIATION 5.97 • n=27 Participants
Sex: Female, Male Female	385 Participants n=93 Participants	390 Participants n=4 Participants	775 Participants n=27 Participants
Sex: Female, Male Male	389 Participants n=93 Participants	375 Participants n=4 Participants	764 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	758 Participants n=93 Participants	756 Participants n=4 Participants	1514 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants	1 Participants n=4 Participants	7 Participants n=27 Participants

PRIMARY outcome

Timeframe: Day 28 post-vaccination

Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.

GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution.

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=769 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=758 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years A/H1N1: Day 28: 60-64 years	471 titers Interval 416.0 to 533.0	248 titers Interval 217.0 to 283.0
Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years A/H3N2: Day 28: 60-64 years	303 titers Interval 262.0 to 350.0	178 titers Interval 154.0 to 206.0
Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years B1: Day 28: 60-64 years	497 titers Interval 450.0 to 548.0	330 titers Interval 297.0 to 367.0
Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years B2: Day 28: 60-64 years	766 titers Interval 690.0 to 849.0	433 titers Interval 391.0 to 480.0
Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years A/H1N1: Day 28: >= 65 years	286 titers Interval 250.0 to 326.0	162 titers Interval 139.0 to 190.0
Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years A/H3N2: Day 28: >=65 years	324 titers Interval 281.0 to 374.0	151 titers Interval 129.0 to 176.0
Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years B1: Day 28: >=65 years	405 titers Interval 366.0 to 447.0	262 titers Interval 236.0 to 291.0
Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years B2: Day 28: >=65 years	536 titers Interval 485.0 to 592.0	305 titers Interval 274.0 to 340.0

SECONDARY outcome

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

Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.

GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution.

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=769 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=758 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants A/H1N1: Day 0	48.6 titers Interval 43.4 to 54.4	46.2 titers Interval 41.4 to 51.7
Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants A/H1N1: Day 28	365 titers Interval 333.0 to 400.0	200 titers Interval 181.0 to 222.0
Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants A/H3N2: Day 0	13.3 titers Interval 12.3 to 14.4	13.0 titers Interval 12.0 to 14.1
Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants A/H3N2: Day 28	313 titers Interval 283.0 to 347.0	164 titers Interval 148.0 to 182.0
Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants B1: Day 0	63.9 titers Interval 57.7 to 70.7	74.5 titers Interval 67.3 to 82.4
Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants B1: Day 28	447 titers Interval 417.0 to 480.0	294 titers Interval 272.0 to 316.0
Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants B2: Day 0	89.7 titers Interval 80.5 to 99.9	96.6 titers Interval 86.9 to 107.0
Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants B2: Day 28	638 titers Interval 594.0 to 686.0	363 titers Interval 337.0 to 392.0

SECONDARY outcome

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

Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.

GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution.

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=769 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=758 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years A/H1N1: Day 0: 60-64 Years	50.2 titers Interval 42.7 to 59.0	50.0 titers Interval 42.6 to 58.8
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years A/H1N1: Day 28: 60-64 Years	471 titers Interval 416.0 to 533.0	248 titers Interval 217.0 to 283.0
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years A/H3N2: Day 0: 60-64 Years	11.5 titers Interval 10.4 to 12.8	12.5 titers Interval 11.2 to 14.0
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years A/H3N2: Day 28: 60-64 Years	303 titers Interval 262.0 to 350.0	178 titers Interval 154.0 to 206.0
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years B1: Day 0: 60-64 Years	54.7 titers Interval 47.4 to 63.2	68.7 titers Interval 59.4 to 79.5
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years B1: Day 28: 60-64 Years	497 titers Interval 450.0 to 548.0	330 titers Interval 297.0 to 367.0
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years B2: Day 0: 60-64 Years	80.4 titers Interval 68.6 to 94.3	93.2 titers Interval 79.5 to 109.0
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years B2: Day 28: 60-64 Years	766 titers Interval 690.0 to 849.0	433 titers Interval 391.0 to 480.0
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years A/H1N1: Day 0: >=65 Years	47.1 titers Interval 40.1 to 55.2	42.8 titers Interval 36.6 to 50.0
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years A/H1N1: Day 28: >=65 Years	286 titers Interval 250.0 to 326.0	162 titers Interval 139.0 to 190.0
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years A/H3N2: Day 0: >=65 Years	15.2 titers Interval 13.5 to 17.1	13.5 titers Interval 12.1 to 15.0
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years A/H3N2: Day 28: >=65 Years	324 titers Interval 281.0 to 374.0	151 titers Interval 129.0 to 176.0
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years B1: Day 0: >=65 Years	74.2 titers Interval 64.3 to 85.6	80.7 titers Interval 70.1 to 92.9
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years B1: Day 28: >=65 Years	405 titers Interval 366.0 to 447.0	262 titers Interval 236.0 to 291.0
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years B2: Day 0: >=65 Years	99.7 titers Interval 86.1 to 115.0	100 titers Interval 86.8 to 115.0
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years B2: Day 28: >=65 Years	536 titers Interval 485.0 to 592.0	305 titers Interval 274.0 to 340.0

SECONDARY outcome

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

Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.

GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=769 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=758 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants A/H1N1: Day 28/Day 0	7.50 ratio Interval 6.68 to 8.42	4.34 ratio Interval 3.88 to 4.84
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants A/H3N2: Day 28/Day 0	23.7 ratio Interval 21.4 to 26.1	12.6 ratio Interval 11.3 to 14.0
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants B1: Day 28/Day 0	7.02 ratio Interval 6.34 to 7.77	3.95 ratio Interval 3.56 to 4.38
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants B2: Day 28/Day 0	7.13 ratio Interval 6.44 to 7.9	3.77 ratio Interval 3.42 to 4.15

SECONDARY outcome

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

Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.

GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=769 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=758 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years A/H1N1: Day 28/Day 0: 60-64 Years	9.36 ratio Interval 7.86 to 11.1	4.96 ratio Interval 4.2 to 5.85
Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years A/H3N2: Day 28/Day 0: 60-64 Years	26.2 ratio Interval 22.8 to 30.2	14.2 ratio Interval 12.2 to 16.6
Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years B1: Day 28/Day 0: 60-64 Years	9.07 ratio Interval 7.84 to 10.5	4.80 ratio Interval 4.11 to 5.6
Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years B2: Day 28/Day 0: 60-64 Years	9.52 ratio Interval 8.19 to 11.1	4.66 ratio Interval 4.03 to 5.39
Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years A/H1N1: Day 28/Day 0: >=65 Years	6.07 ratio Interval 5.22 to 7.05	3.80 ratio Interval 3.27 to 4.41
Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years A/H3N2: Day 28/Day 0: >=65 Years	21.4 ratio Interval 18.6 to 24.7	11.2 ratio Interval 9.66 to 13.0
Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years B1: Day 28/Day 0: >=65 Years	5.48 ratio Interval 4.78 to 6.28	3.25 ratio Interval 2.83 to 3.73
Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years B2: Day 28/Day 0: >=65 Years	5.39 ratio Interval 4.72 to 6.15	3.06 ratio Interval 2.7 to 3.46

SECONDARY outcome

Timeframe: Day 28 post-vaccination

Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Neutralizing Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of participants (all age group participants) with neutralizing antibody titers \>=40 (1/dilution) is reported in the outcome measure.

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=769 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=758 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) A/H1N1: Day 28	96.6 percentage of participants Interval 95.1 to 97.8	88.4 percentage of participants Interval 85.9 to 90.6
Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) A/H3N2: Day 28	93.8 percentage of participants Interval 91.8 to 95.4	86.4 percentage of participants Interval 83.8 to 88.8
Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) B1: Day 28	99.5 percentage of participants Interval 98.7 to 99.9	99.2 percentage of participants Interval 98.3 to 99.7
Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) B2: Day 28	99.5 percentage of participants Interval 98.7 to 99.9	98.3 percentage of participants Interval 97.1 to 99.1

SECONDARY outcome

Timeframe: Day 28 post-vaccination

Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Neutralizing Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of participants (aged 60-64 Years and \>=65 Years) with neutralizing antibody titers \>=40 (1/dilution) is reported in the outcome measure.

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=769 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=758 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) A/H1N1: Day 28: 60-64 Years	98.1 percentage of participants Interval 96.2 to 99.3	92.3 percentage of participants Interval 89.1 to 94.8
Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) A/H3N2: Day 28: 60-64 Years	94.9 percentage of participants Interval 92.2 to 96.9	89.1 percentage of participants Interval 85.5 to 92.1
Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) B1: Day 28: 60-64 Years	100 percentage of participants Interval 99.0 to 100.0	99.5 percentage of participants Interval 98.1 to 99.9
Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) B2: Day 28: 60-64 Years	99.7 percentage of participants Interval 98.5 to 100.0	99.5 percentage of participants Interval 98.1 to 99.9
Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) A/H1N1: Day 28: >=65 Years	95.2 percentage of participants Interval 92.5 to 97.1	84.5 percentage of participants Interval 80.5 to 88.0
Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) A/H3N2: Day 28: >=65 Years	92.6 percentage of participants Interval 89.5 to 95.0	83.7 percentage of participants Interval 79.6 to 87.3
Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) B1: Day 28: >=65 Years	99.0 percentage of participants Interval 97.4 to 99.7	99.0 percentage of participants Interval 97.3 to 99.7
Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) B2: Day 28: >=65 Years	99.2 percentage of participants Interval 97.8 to 99.8	97.1 percentage of participants Interval 94.9 to 98.6

SECONDARY outcome

Timeframe: Day 28 post-vaccination

Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 1:10 (1/dilution) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. Percentage of participants (all age group participants) achieving seroconversion is reported in the outcome measure.

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=769 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=758 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens A/H1N1: Day 28	62.1 percentage of participants Interval 58.6 to 65.6	39.2 percentage of participants Interval 35.7 to 42.8
Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens A/H3N2: Day 28	88.1 percentage of participants Interval 85.6 to 90.3	74.2 percentage of participants Interval 71.0 to 77.3
Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens B1: Day 28	62.5 percentage of participants Interval 58.9 to 65.9	41.2 percentage of participants Interval 37.7 to 44.8
Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens B2: Day 28	62.7 percentage of participants Interval 59.2 to 66.2	41.6 percentage of participants Interval 38.0 to 45.2

SECONDARY outcome

Timeframe: Day 28 post-vaccination

Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 (1/dilution) and a post-vaccination titer \>= 1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. Percentage of participants (aged 60-64 Years and \>=65 Years) achieving seroconversion is reported in the outcome measure.

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=769 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=758 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens B1: Day 28: >=65 Years	56.9 percentage of participants Interval 51.8 to 61.9	34.7 percentage of participants Interval 30.0 to 39.8
Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens A/H1N1: Day 28: 60-64 Years	66.5 percentage of participants Interval 61.5 to 71.2	41.4 percentage of participants Interval 36.4 to 46.5
Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens A/H3N2: Day 28: 60-64 Years	89.4 percentage of participants Interval 85.8 to 92.3	76.7 percentage of participants Interval 72.1 to 80.8
Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens B1: Day 28: 60-64 Years	68.2 percentage of participants Interval 63.2 to 72.8	47.7 percentage of participants Interval 42.6 to 52.9
Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens B2: Day 28: 60-64 Years	70.6 percentage of participants Interval 65.7 to 75.1	48.5 percentage of participants Interval 43.4 to 53.7
Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens A/H1N1: Day 28: >=65 Years	57.9 percentage of participants Interval 52.8 to 62.8	37.0 percentage of participants Interval 32.1 to 42.1
Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens A/H3N2: Day 28: >=65 Years	87.0 percentage of participants Interval 83.2 to 90.1	71.8 percentage of participants Interval 67.0 to 76.3
Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens B2: Day 28: >=65 Years	55.2 percentage of participants Interval 50.1 to 60.2	34.7 percentage of participants Interval 30.0 to 39.8

SECONDARY outcome

Timeframe: Within 30 minutes post-vaccination

Population: Analysis was performed on safety analysis set (SafAS) which included participants who had received the study vaccine and had any safety data available.

An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=772 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=761 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 7 days post-vaccination

Population: Analysis was performed on the SafAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included induration, bruising, pain, erythema, and swelling.

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=770 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=759 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Number of Participants Reporting Solicited Injection Site Reactions Bruising	12 Participants	7 Participants
Number of Participants Reporting Solicited Injection Site Reactions Erythema	157 Participants	85 Participants
Number of Participants Reporting Solicited Injection Site Reactions Induration	132 Participants	64 Participants
Number of Participants Reporting Solicited Injection Site Reactions Pain	350 Participants	159 Participants
Number of Participants Reporting Solicited Injection Site Reactions Swelling	140 Participants	62 Participants

SECONDARY outcome

Timeframe: Within 7 days post-vaccination

Population: Analysis was performed on the SafAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=770 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=759 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Number of Participants Reporting Solicited Systemic Reactions Fever	18 Participants	4 Participants
Number of Participants Reporting Solicited Systemic Reactions Headache	184 Participants	141 Participants
Number of Participants Reporting Solicited Systemic Reactions Malaise	164 Participants	89 Participants
Number of Participants Reporting Solicited Systemic Reactions Myalgia	202 Participants	93 Participants
Number of Participants Reporting Solicited Systemic Reactions Shivering	128 Participants	54 Participants

SECONDARY outcome

Timeframe: Within 28 days post-vaccination

Population: Analysis was performed on SafAS population.

An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination.

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=772 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=761 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Number of Participants Reporting Unsolicited Adverse Events (AEs)	190 Participants	172 Participants

SECONDARY outcome

Timeframe: From Day 0 up to 6 months post-vaccination

Population: Analysis was performed on the SafAS population.

A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.

Outcome measures

Outcome measures
Measure	Group 1: QIV-HD n=772 Participants Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2: QIV-SD n=761 Participants Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) SAE	17 Participants	21 Participants
Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) AESI	0 Participants	0 Participants

Adverse Events

Group 1 QIV-HD

Serious events: 17 serious events

Other events: 507 other events

Deaths: 2 deaths

Group 2 QIV-SD

Serious events: 21 serious events

Other events: 354 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 QIV-HD n=772 participants at risk Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2 QIV-SD n=761 participants at risk Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Cardiac disorders Acute Myocardial Infarction	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Cardiac disorders Coronary Artery Stenosis	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Cardiac disorders Myocardial Infarction	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.26% 2/761 • Number of events 2 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Gastrointestinal disorders Gastric Perforation	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Gastrointestinal disorders Intestinal Haemorrhage	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Gastrointestinal disorders Large Intestinal Obstruction	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Gastrointestinal disorders Rectal Prolapse	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Infections and infestations Corona Virus Infection	0.26% 2/772 • Number of events 2 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Infections and infestations Pilonidal Cyst	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Infections and infestations Pneumococcal Sepsis	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Infections and infestations Pneumonia	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Injury, poisoning and procedural complications Forearm Fracture	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Injury, poisoning and procedural complications Humerus Fracture	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Injury, poisoning and procedural complications Meniscus Injury	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Injury, poisoning and procedural complications Road Traffic Accident	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Injury, poisoning and procedural complications Thermal Burn	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Metabolism and nutrition disorders Dehydration	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial Carcinoma	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Cancer	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia Vera	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Neoplasm	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Nervous system disorders Cerebral Thrombosis	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Nervous system disorders Cerebrovascular Accident	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Nervous system disorders Loss Of Consciousness	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Nervous system disorders Transient Ischaemic Attack	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Nervous system disorders Vith Nerve Paralysis	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Renal and urinary disorders Nephrolithiasis	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Renal and urinary disorders Urinary Incontinence	0.00% 0/772 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.13% 1/761 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Reproductive system and breast disorders Prostatitis	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Vascular disorders Intermittent Claudication	0.13% 1/772 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	0.00% 0/761 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.

Other adverse events

Other adverse events
Measure	Group 1 QIV-HD n=772 participants at risk Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.	Group 2 QIV-SD n=761 participants at risk Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
General disorders Chills	16.6% 128/772 • Number of events 130 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	7.5% 57/761 • Number of events 58 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
General disorders Injection Site Erythema	20.3% 157/772 • Number of events 158 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	11.2% 85/761 • Number of events 85 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
General disorders Injection Site Induration	17.1% 132/772 • Number of events 133 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	8.4% 64/761 • Number of events 64 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
General disorders Injection Site Pain	45.3% 350/772 • Number of events 350 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	21.2% 161/761 • Number of events 161 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
General disorders Injection Site Swelling	18.1% 140/772 • Number of events 140 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	8.1% 62/761 • Number of events 62 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
General disorders Malaise	21.8% 168/772 • Number of events 168 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	11.8% 90/761 • Number of events 90 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Musculoskeletal and connective tissue disorders Myalgia	26.7% 206/772 • Number of events 207 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	12.4% 94/761 • Number of events 94 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
Nervous system disorders Headache	24.6% 190/772 • Number of events 196 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.	19.6% 149/761 • Number of events 156 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination. Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.

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