Trial Outcomes & Findings for A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above. (NCT NCT02214225)

NCT ID: NCT02214225

Last Updated: 2017-03-13

Results Overview

Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 3484 participants
• Primary outcome timeframe: 21 days after vaccination.
• Results posted on: 2017-03-13

Participant Flow

First Patient In: 15-AUG-2014, Last Patient Last Visit: 20-APR-2015. Number of activated sites that enrolled subjects: 31 (all based in USA).

Number of subjects screened: 3673. Number of subjects randomized: 3484.

Participant milestones

Measure	Quadrivalent Influenza Vaccine (QIV) The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle	Trivalent Influenza Vaccine (TIV-1) The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-2) The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.
Overall Study STARTED	1741	871	872
Overall Study COMPLETED	1686	852	850
Overall Study NOT COMPLETED	55	19	22

Reasons for withdrawal

Measure	Quadrivalent Influenza Vaccine (QIV) The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle	Trivalent Influenza Vaccine (TIV-1) The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-2) The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.
Overall Study Lost to Follow-up	46	18	18
Overall Study Withdrawal by Subject	2	0	2
Overall Study Death	5	0	1
Overall Study randomized in error, not vaccinated	2	1	1

Baseline Characteristics

A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.

Baseline characteristics by cohort

Measure	Quadrivalent Influenza Vaccine (QIV) n=1741 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). QIV dose: One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=871 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). TIV-1 dose: One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-2) n=872 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). TIV-2 dose: One 0.5 mL intramuscular dose into the deltoid muscle.	Total n=3484 Participants Total of all reporting groups
Age, Continuous	58.3 years STANDARD_DEVIATION 18.10 • n=5 Participants	58.2 years STANDARD_DEVIATION 18.10 • n=7 Participants	58.3 years STANDARD_DEVIATION 17.89 • n=5 Participants	58.3 years STANDARD_DEVIATION 18.04 • n=4 Participants
Age, Customized 18 to 49 years	510 participants n=5 Participants	255 participants n=7 Participants	255 participants n=5 Participants	1020 participants n=4 Participants
Age, Customized 50 to 64 years	361 participants n=5 Participants	179 participants n=7 Participants	181 participants n=5 Participants	721 participants n=4 Participants
Age, Customized 65 to 74 years	541 participants n=5 Participants	271 participants n=7 Participants	270 participants n=5 Participants	1082 participants n=4 Participants
Age, Customized => 75 years	329 participants n=5 Participants	166 participants n=7 Participants	166 participants n=5 Participants	661 participants n=4 Participants
Sex: Female, Male Female	971 Participants n=5 Participants	511 Participants n=7 Participants	510 Participants n=5 Participants	1992 Participants n=4 Participants
Sex: Female, Male Male	770 Participants n=5 Participants	360 Participants n=7 Participants	362 Participants n=5 Participants	1492 Participants n=4 Participants
Region of Enrollment United States	1741 participants n=5 Participants	871 participants n=7 Participants	872 participants n=5 Participants	3484 participants n=4 Participants

PRIMARY outcome

Timeframe: 21 days after vaccination.

Population: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.

Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=1691 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=1704 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years)	bioCSL TIV-2 (B/VIC) (≥ 65 Years)
Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population). A/H1N1	—	303.0 Titer Interval 5.0 to 8127.0	—	280.2 Titer Interval 5.0 to 6451.0	—	—
Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population). A/H3N2	—	488.7 Titer Interval 5.0 to 10240.0	—	454.2 Titer Interval 5.0 to 12902.0	—	—
Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population). B/Yamagata	—	64.3 Titer Interval 5.0 to 2560.0	—	55.7 Titer Interval 5.0 to 2560.0	—	—
Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population). B/Victoria	—	87.9 Titer Interval 5.0 to 2560.0	—	82.2 Titer Interval 5.0 to 5120.0	—	—

PRIMARY outcome

Timeframe: 21 days after vaccination.

Population: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.

SCR (defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination HI titer ≥ 1:10 and a 4-fold increase in postvaccination HI titer) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=1691 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=1704 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years)	bioCSL TIV-2 (B/VIC) (≥ 65 Years)
The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years. A/H3N2	—	40.9 percentage of participants	—	39.3 percentage of participants	—	—
The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years. A/H1N1	—	38.8 percentage of participants	—	37.7 percentage of participants	—	—
The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years. B/Yamagata	—	31.0 percentage of participants	—	27.8 percentage of participants	—	—
The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years. B/Victoria	—	40.3 percentage of participants	—	38.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: 21 days after vaccination.

Population: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.

Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.

Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of GMT ratios as described for the primary endpoint.

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) n=859 Participants bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=835 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) n=856 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=845 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years)	bioCSL TIV-2 (B/VIC) (≥ 65 Years)
Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population). A/H1N1	199.8 Titer Interval 5.0 to 4064.0	432.7 Titer Interval 10.0 to 8127.0	211.4 Titer Interval 5.0 to 3225.0	402.8 Titer Interval 20.0 to 6451.0	—	—
Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population). A/H3N2	400.0 Titer Interval 5.0 to 5120.0	569.1 Titer Interval 5.0 to 10240.0	419.5 Titer Interval 5.0 to 10240.0	515.1 Titer Interval 20.0 to 12902.0	—	—
Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population). B/Yamagata	39.1 Titer Interval 5.0 to 1280.0	92.3 Titer Interval 5.0 to 2560.0	43.3 Titer Interval 5.0 to 1613.0	79.3 Titer Interval 5.0 to 2560.0	—	—
Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population). B/Victoria	68.4 Titer Interval 5.0 to 2560.0	110.7 Titer Interval 10.0 to 2560.0	66.1 Titer Interval 5.0 to 2560.0	95.2 Titer Interval 5.0 to 5120.0	—	—

SECONDARY outcome

Timeframe: 21 days after vaccination.

Population: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.

Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of SCR differences as described for the primary endpoint.

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) n=859 Participants bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=835 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) n=856 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=845 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years)	bioCSL TIV-2 (B/VIC) (≥ 65 Years)
The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population). A/H1N1	26.4 percentage of participants analyzed	51.3 percentage of participants analyzed	26.6 percentage of participants analyzed	49.1 percentage of participants analyzed	—	—
The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population). A/H3N2	27.0 percentage of participants analyzed	56.3 percentage of participants analyzed	25.9 percentage of participants analyzed	51.7 percentage of participants analyzed	—	—
The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population). B/Yamagata	14.4 percentage of participants analyzed	45.7 percentage of participants analyzed	16.6 percentage of participants analyzed	41.3 percentage of participants analyzed	—	—
The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population). B/Victoria	24.7 percentage of participants analyzed	57.6 percentage of participants analyzed	23.5 percentage of participants analyzed	53.0 percentage of participants analyzed	—	—

SECONDARY outcome

Timeframe: 21 days after vaccination.

Population: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.

Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.

(GMT dispersion values are based on unadjusted GMT values.)

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=1691 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=854 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years)	bioCSL TIV-2 (B/VIC) (≥ 65 Years)
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population). B/Yamagata (overall, ≥18 years)	—	62.9 Titer Interval 5.0 to 2560.0	—	42.7 Titer Interval 5.0 to 2560.0	—	—
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population). B/Victoria (overall, ≥18 years)	—	86.9 Titer Interval 5.0 to 2560.0	—	55.4 Titer Interval 5.0 to 5120.0	—	—
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population). B/Yamagata (18 to <65 years)	—	89.9 Titer Interval 5.0 to 2560.0	—	53.8 Titer Interval 5.0 to 2560.0	—	—
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population). B/Victoria (18 to <65 years)	—	113.5 Titer Interval 10.0 to 2560.0	—	64.3 Titer Interval 5.0 to 5120.0	—	—
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population). B/Yamagata (≥65 years)	—	43.8 Titer Interval 5.0 to 1613.0	—	33.6 Titer Interval 5.0 to 1280.0	—	—
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population). B/Victoria (≥65 years)	—	64.1 Titer Interval 5.0 to 2560.0	—	46.3 Titer Interval 5.0 to 2560.0	—	—

SECONDARY outcome

Timeframe: 21 days after vaccination.

Population: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.

Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The SCR difference was calculated as bioCSL QIV SCR minus bioCSL TIV SCR, which is the reverse of how it was calculated for the non-inferiority analyses. For the SCR comparison superiority was demonstrated if the lower limit of the two-sided 95% CI of the difference of the seroconversion rates was greater than 0 for each B strain in QIV compared with the corresponding B strain not contained in each TIV.

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=1691 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=854 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years)	bioCSL TIV-2 (B/VIC) (≥ 65 Years)
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population) B/Yamagata (overall, ≥18 years)	—	31.0 percentage of participants analyzed	—	15.6 percentage of participants analyzed	—	—
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population) B/Victoria (overall, ≥18 years)	—	40.3 percentage of participants analyzed	—	20.3 percentage of participants analyzed	—	—
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population) B/Yamagata (18 to <65 years)	—	45.7 percentage of participants analyzed	—	22.8 percentage of participants analyzed	—	—
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population) B/Victoria (18 to <65 years)	—	57.6 percentage of participants analyzed	—	29.0 percentage of participants analyzed	—	—
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population) B/Yamagata (≥65 years)	—	16.6 percentage of participants analyzed	—	8.6 percentage of participants analyzed	—	—
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population) B/Victoria (≥65 years)	—	23.5 percentage of participants analyzed	—	11.6 percentage of participants analyzed	—	—

SECONDARY outcome

Timeframe: 21 days after vaccination.

Population: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.

The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of geometric mean HI titers (GMT) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) n=856 Participants bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=835 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) n=421 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=424 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years) n=430 Participants	bioCSL TIV-2 (B/VIC) (≥ 65 Years) n=429 Participants
Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination. A/H1N1 (pre-vaccination)	75.7 Titer Interval 69.93 to 81.84	78.1 Titer Interval 70.51 to 86.41	82.8 Titer Interval 71.98 to 95.17	82.3 Titer Interval 71.57 to 94.74	72.0 Titer Interval 64.58 to 80.25	69.2 Titer Interval 61.91 to 77.27
Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination. A/H3N2 (pre-vaccination)	153.0 Titer Interval 141.9 to 165.05	97.4 Titer Interval 87.93 to 107.96	105.7 Titer Interval 92.63 to 120.53	96.1 Titer Interval 83.51 to 110.64	139.0 Titer Interval 123.74 to 156.16	142.7 Titer Interval 126.73 to 160.75
Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination. B/Yamagata (pre-vaccination)	20.3 Titer Interval 19.01 to 21.7	23.7 Titer Interval 21.89 to 25.61	23.7 Titer Interval 21.32 to 26.42	24.7 Titer Interval 22.09 to 27.6	18.6 Titer Interval 17.02 to 20.35	19.6 Titer Interval 17.77 to 21.72
Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination. B/Victoria (pre-vaccination)	24.4 Titer Interval 22.84 to 26.17	20.4 Titer Interval 18.95 to 21.85	21.7 Titer Interval 19.54 to 24.04	20.4 Titer Interval 18.49 to 22.56	23.4 Titer Interval 21.31 to 25.73	25.1 Titer Interval 22.73 to 27.63
Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination. A/H1N1 (post-vaccination)	175.9 Titer Interval 163.61 to 189.11	429.9 Titer Interval 400.38 to 461.61	433.9 Titer Interval 391.46 to 481.01	432.8 Titer Interval 392.96 to 476.66	169.3 Titer Interval 152.67 to 187.68	158.7 Titer Interval 143.15 to 175.95
Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination. A/H3N2 (post-vaccination)	356.4 Titer Interval 333.25 to 381.14	533.3 Titer Interval 496.04 to 573.37	532.5 Titer Interval 482.62 to 587.64	499.4 Titer Interval 449.73 to 554.62	336.6 Titer Interval 305.26 to 371.11	330.3 Titer Interval 297.27 to 367.07
Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination. B/Yamagata (post-vaccination)	38.1 Titer Interval 35.5 to 40.86	97.4 Titer Interval 90.04 to 105.35	53.5 Titer Interval 47.85 to 59.88	84.6 Titer Interval 75.64 to 94.65	33.2 Titer Interval 30.18 to 36.51	28.6 Titer Interval 25.75 to 31.69
Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination. B/Victoria (post-vaccination)	54.0 Titer Interval 49.97 to 58.4	111.9 Titer Interval 103.57 to 120.82	103.0 Titer Interval 92.38 to 114.78	55.5 Titer Interval 49.85 to 61.77	38.7 Titer Interval 34.96 to 42.92	57.4 Titer Interval 51.34 to 64.29

SECONDARY outcome

Timeframe: 21 days after vaccination.

Population: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.

The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 assessed in terms of Geometric Mean Fold Increase (GMFI, defined as the geometric mean of the fold increases of postvaccination antibody titer over the prevaccination antibody titer) by Age Cohort (Per Protocol Population).

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) n=856 Participants bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=835 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) n=421 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=424 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years) n=430 Participants	bioCSL TIV-2 (B/VIC) (≥ 65 Years) n=429 Participants
Geometric Mean Fold Titer Change From Prevaccination to Postvaccination. A/H1N1	2.3 Fold Change Titer (GMFI) Interval 2.18 to 2.48	5.5 Fold Change Titer (GMFI) Interval 4.96 to 6.11	5.2 Fold Change Titer (GMFI) Interval 4.49 to 6.12	5.3 Fold Change Titer (GMFI) Interval 4.53 to 6.1	2.4 Fold Change Titer (GMFI) Interval 2.14 to 2.58	2.3 Fold Change Titer (GMFI) Interval 2.09 to 2.52
Geometric Mean Fold Titer Change From Prevaccination to Postvaccination. A/H3N2	2.3 Fold Change Titer (GMFI) Interval 2.19 to 2.47	5.5 Fold Change Titer (GMFI) Interval 4.98 to 6.02	5.0 Fold Change Titer (GMFI) Interval 4.43 to 5.74	5.2 Fold Change Titer (GMFI) Interval 4.56 to 5.91	2.4 Fold Change Titer (GMFI) Interval 2.21 to 2.65	2.3 Fold Change Titer (GMFI) Interval 2.1 to 2.55
Geometric Mean Fold Titer Change From Prevaccination to Postvaccination. B/Yamagata	1.9 Fold Change Titer (GMFI) Interval 1.79 to 1.97	4.1 Fold Change Titer (GMFI) Interval 3.78 to 4.47	2.3 Fold Change Titer (GMFI) Interval 2.08 to 2.45	3.4 Fold Change Titer (GMFI) Interval 3.05 to 3.85	1.8 Fold Change Titer (GMFI) Interval 1.67 to 1.91	1.5 Fold Change Titer (GMFI) Interval 1.38 to 1.54
Geometric Mean Fold Titer Change From Prevaccination to Postvaccination. B/Victoria	2.2 Fold Change Titer (GMFI) Interval 2.08 to 2.34	5.5 Fold Change Titer (GMFI) Interval 5.04 to 5.99	4.8 Fold Change Titer (GMFI) Interval 4.21 to 5.36	2.7 Fold Change Titer (GMFI) Interval 2.46 to 3.0	1.7 Fold Change Titer (GMFI) Interval 1.54 to 1.77	2.3 Fold Change Titer (GMFI) Interval 2.1 to 2.5

SECONDARY outcome

Timeframe: 21 days after vaccination.

Population: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.

The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of percentage of subjects with a HI titer ≥40 (seroprotection rates) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) n=856 Participants bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=835 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) n=421 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=424 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years) n=430 Participants	bioCSL TIV-2 (B/VIC) (≥ 65 Years) n=429 Participants
Seroprotection Rates Prevaccination and Postvaccination. A/H1N1 (pre-vaccination)	78.5 percentage of participants Interval 75.6 to 81.2	73.2 percentage of participants Interval 70.0 to 76.2	75.5 percentage of participants Interval 71.1 to 79.6	76.9 percentage of participants Interval 72.6 to 80.8	80.0 percentage of participants Interval 75.9 to 83.7	77.4 percentage of participants Interval 73.1 to 81.3
Seroprotection Rates Prevaccination and Postvaccination. A/H3N2 (pre-vaccination)	92.9 percentage of participants Interval 90.9 to 94.5	78.3 percentage of participants Interval 75.4 to 81.1	81.5 percentage of participants Interval 77.4 to 85.1	77.1 percentage of participants Interval 72.8 to 81.0	90.9 percentage of participants Interval 87.8 to 93.5	88.8 percentage of participants Interval 85.4 to 91.6
Seroprotection Rates Prevaccination and Postvaccination. B/Yamagata (pre-vaccination	33.2 percentage of participants Interval 30.0 to 36.4	39.9 percentage of participants Interval 36.5 to 43.3	40.9 percentage of participants Interval 36.1 to 45.7	39.9 percentage of participants Interval 35.2 to 44.7	29.1 percentage of participants Interval 24.8 to 33.6	31.2 percentage of participants Interval 26.9 to 35.9
Seroprotection Rates Prevaccination and Postvaccination. B/Victoria (pre-vaccination)	38.7 percentage of participants Interval 35.4 to 42.0	33.5 percentage of participants Interval 30.3 to 36.8	35.9 percentage of participants Interval 31.3 to 40.7	32.8 percentage of participants Interval 28.3 to 37.5	36.3 percentage of participants Interval 31.7 to 41.0	40.1 percentage of participants Interval 35.4 to 44.9
Seroprotection Rates Prevaccination and Postvaccination. A/H1N1 (post-vaccination)	94.6 percentage of participants Interval 92.9 to 96.0	99.0 percentage of participants Interval 98.1 to 99.6	99.0 percentage of participants Interval 97.6 to 99.7	100.0 percentage of participants Interval 99.1 to 100.0	95.8 percentage of participants Interval 93.5 to 97.5	95.3 percentage of participants Interval 92.9 to 97.1
Seroprotection Rates Prevaccination and Postvaccination. A/H3N2 (post-vaccination)	99.8 percentage of participants Interval 99.2 to 100.0	99.0 percentage of participants Interval 98.1 to 99.6	98.8 percentage of participants Interval 97.3 to 99.6	98.8 percentage of participants Interval 97.3 to 99.6	99.1 percentage of participants Interval 97.6 to 99.7	98.1 percentage of participants Interval 96.4 to 99.2
Seroprotection Rates Prevaccination and Postvaccination. B/Yamagata (post-vaccination)	57.5 percentage of participants Interval 54.1 to 60.8	84.3 percentage of participants Interval 81.7 to 86.7	68.4 percentage of participants Interval 63.7 to 72.8	81.4 percentage of participants Interval 77.3 to 85.0	54.2 percentage of participants Interval 49.3 to 59.0	46.2 percentage of participants Interval 41.4 to 51.0
Seroprotection Rates Prevaccination and Postvaccination. B/Victoria (post-vaccination)	68.3 percentage of participants Interval 65.1 to 71.4	86.7 percentage of participants Interval 84.2 to 88.9	86.2 percentage of participants Interval 82.6 to 89.4	68.2 percentage of participants Interval 63.5 to 72.6	54.4 percentage of participants Interval 49.6 to 59.2	68.3 percentage of participants Interval 63.7 to 72.7

SECONDARY outcome

Timeframe: 21 days after vaccination.

Population: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.

The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bio CSL TIV-2 was assessed in terms of the seroconversion rate, ie, percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer. Data presented in age cohorts (per protocol population).

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) n=856 Participants bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=835 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) n=421 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=424 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years) n=430 Participants	bioCSL TIV-2 (B/VIC) (≥ 65 Years) n=429 Participants
Seroconversion Rates A/H1N1	26.6 percentage of participants Interval 23.7 to 29.7	51.3 percentage of participants Interval 47.8 to 54.7	47.7 percentage of participants Interval 42.9 to 52.6	50.5 percentage of participants Interval 45.6 to 55.3	27.4 percentage of participants Interval 23.3 to 31.9	25.4 percentage of participants Interval 21.4 to 29.8
Seroconversion Rates A/H3N2	25.9 percentage of participants Interval 23.0 to 29.0	56.3 percentage of participants Interval 52.8 to 59.7	50.6 percentage of participants Interval 45.7 to 55.5	52.8 percentage of participants Interval 48.0 to 57.7	28.6 percentage of participants Interval 24.4 to 33.1	25.4 percentage of participants Interval 21.4 to 29.8
Seroconversion Rates B/Yamagata	16.6 percentage of participants Interval 14.2 to 19.3	45.7 percentage of participants Interval 42.3 to 49.2	22.8 percentage of participants Interval 18.9 to 27.1	41.3 percentage of participants Interval 36.5 to 46.1	14.4 percentage of participants Interval 11.2 to 18.1	8.6 percentage of participants Interval 6.1 to 11.7
Seroconversion Rates B/Victoria	23.5 percentage of participants Interval 20.7 to 26.5	57.6 percentage of participants Interval 54.2 to 61.0	53.0 percentage of participants Interval 48.1 to 57.8	29.0 percentage of participants Interval 24.7 to 33.6	11.6 percentage of participants Interval 8.8 to 15.0	24.7 percentage of participants Interval 20.7 to 29.1

SECONDARY outcome

Timeframe: For 7 days following vaccination.

Population: The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.

The overall number of subjects experiencing at least one event of a local and systemic solicited AE, and the overall number of subjects with at least one severe (grade 3) local and systemic solicited AE.

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=1721 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) n=864 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=864 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years)	bioCSL TIV-2 (B/VIC) (≥ 65 Years)
The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs). Severe (grade 3) solicited AEs	—	42 participants	24 participants	15 participants	—	—
The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs). Frequency of solicited AEs	—	803 participants	397 participants	391 participants	—	—

SECONDARY outcome

Timeframe: For 28 days following vaccination.

Population: The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.

The number of subjects experiencing at least one episode of each event.

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=1721 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) n=864 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=864 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years)	bioCSL TIV-2 (B/VIC) (≥ 65 Years)
The Frequency of Cellulitis-like Reaction and Cellulitis.	—	0 participants	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: For 28 days following vaccination.

Population: The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.

The overall number of subjects experiencing at least one event of an unsolicited AE, and the overall number of subjects with at least one severe (grade 3) unsolicited AE.

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=1721 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) n=864 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=864 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years)	bioCSL TIV-2 (B/VIC) (≥ 65 Years)
The Frequency and Severity of Unsolicited AEs. At least one unsolicited AE	—	351 participants	176 participants	191 participants	—	—
The Frequency and Severity of Unsolicited AEs. Severe (grade 3) unsolicited AE	—	73 participants	33 participants	29 participants	—	—

SECONDARY outcome

Timeframe: For 6 months following vaccination.

Population: The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.

The number of participants reporting Serious Adverse Events for 6 months following vaccination.

Outcome measures

Measure	SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years) bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2. bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.	Postvaccination GMT: bioCSL QIV n=1721 Participants bioCSL QIV, Adults 18 years and older, N=1691. 18 to \< 65 years, n=835. =\> 65 years, n=856.	Trivalent Influenza Vaccine (TIV-2) n=864 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-1) n=864 Participants The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	bioCSL TIV-1 (B/YAM) (≥ 65 Years)	bioCSL TIV-2 (B/VIC) (≥ 65 Years)
The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination.	—	39 participants	13 participants	14 participants	—	—

Adverse Events

Quadrivalent Influenza Vaccine (QIV)

Serious events: 39 serious events

Other events: 872 other events

Deaths: 0 deaths

Trivalent Influenza Vaccine (TIV-1)

Serious events: 14 serious events

Other events: 445 other events

Deaths: 0 deaths

Trivalent Influenza Vaccine (TIV-2)

Serious events: 13 serious events

Other events: 397 other events

Deaths: 0 deaths

Serious adverse events

Measure	Quadrivalent Influenza Vaccine (QIV) n=1721 participants at risk The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle	Trivalent Influenza Vaccine (TIV-1) n=864 participants at risk The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-2) n=864 participants at risk The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.
Infections and infestations Bronchitis	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Infections and infestations Pneumonia	0.12% 2/1721 • Number of events 2 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.23% 2/864 • Number of events 2 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Infections and infestations Sepsis	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.23% 2/864 • Number of events 2 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Infections and infestations Atypical pneumonia	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Infections and infestations Cellulitis	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Infections and infestations Diverticulitis	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Infections and infestations Pelvic inflammatory disease	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Infections and infestations Urinary tract infection	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.12% 2/1721 • Number of events 2 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumor benign	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Metabolism and nutrition disorders Dehydration	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Psychiatric disorders Bipolar I disorder	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Psychiatric disorders Bipolar disorder	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Nervous system disorders Cerebrovascular accident	0.12% 2/1721 • Number of events 2 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Nervous system disorders Transient ischemic attack	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Nervous system disorders Carotid artery disease	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Nervous system disorders Carotid artery stenosis	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Nervous system disorders Hemorrhage intracranial	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Nervous system disorders Ischemic stroke	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Nervous system disorders Spasmodic dysphonia	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Nervous system disorders Syncope	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Nervous system disorders Thalamic infarction	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Cardiac disorders Atrial fibrillation	0.17% 3/1721 • Number of events 3 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.35% 3/864 • Number of events 3 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Cardiac disorders Myocardial infarction	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Cardiac disorders Cardiac failure congestive	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Cardiac disorders Acute myocardial infarction	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Cardiac disorders Atrioventricular block second degree	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Cardiac disorders Bundle branch block left	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Cardiac disorders Cardiac failure	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Cardiac disorders Coronary artery disease	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Cardiac disorders Sick sinus syndrome	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Cardiac disorders Ventricular arrhythmia	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.12% 2/1721 • Number of events 2 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Renal and urinary disorders Hydronephrosis	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Renal and urinary disorders Renal failure	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Renal and urinary disorders Renal failure acute	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Renal and urinary disorders Renal impairment	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
General disorders Chest pain	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
General disorders Asthenia	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
General disorders Pyrexia	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Investigations Oxygen saturation decreased	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Injury, poisoning and procedural complications Esophageal injury	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Injury, poisoning and procedural complications Postprocedural hematuria	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Injury, poisoning and procedural complications Road traffic accident	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Injury, poisoning and procedural complications Upper limb fracture	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Vascular disorders Accelerated hypertension	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Vascular disorders Deep vein thrombosis	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Vascular disorders Granulomatosis with polyangiitis	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Vascular disorders Hypertension	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.23% 2/864 • Number of events 2 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Respiratory, thoracic and mediastinal disorders Asthma	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Gastrointestinal disorders Abominable pain upper	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Gastrointestinal disorders Colitis	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Gastrointestinal disorders Diverticulum intestinal	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Gastrointestinal disorders Pancreatitis acute	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Gastrointestinal disorders Small intestinal obstruction	0.06% 1/1721 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/1721 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.12% 1/864 • Number of events 1 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	0.00% 0/864 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.

Other adverse events

Measure	Quadrivalent Influenza Vaccine (QIV) n=1721 participants at risk The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle	Trivalent Influenza Vaccine (TIV-1) n=864 participants at risk The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.	Trivalent Influenza Vaccine (TIV-2) n=864 participants at risk The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season). Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.
General disorders Pain	36.1% 622/1721 • Number of events 629 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	33.1% 286/864 • Number of events 292 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	35.8% 309/864 • Number of events 316 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Nervous system disorders Headache	15.0% 258/1721 • Number of events 300 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	11.1% 96/864 • Number of events 113 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	13.4% 116/864 • Number of events 133 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Nervous system disorders Malaise	6.6% 114/1721 • Number of events 125 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	7.1% 61/864 • Number of events 67 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	7.2% 62/864 • Number of events 72 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.
Musculoskeletal and connective tissue disorders Myalgia	19.1% 328/1721 • Number of events 352 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	18.6% 161/864 • Number of events 171 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.	18.2% 157/864 • Number of events 173 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination. The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.

Additional Information

Seqirus Clinical Trial Disclosure Lead

Seqirus

Email: Seqirus.ClinicalTrials@Seqirus.com

Results disclosure agreements

• Principal investigator is a sponsor employee bioCSL agreements and restrictions on publishing may vary with individual investigators; however, bioCSL will not prohibit any investigator from publishing. bioCSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial. (Note: bioCSL was previously known as CSL Biotherapies; bioCSL QIV \& TIV were called CSL QIV \& TIV in the original protocol)
• Publication restrictions are in place

Restriction type: OTHER