Trial Outcomes & Findings for Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to <65 Years and Elderly 65 Years and Older. (NCT NCT01855945)

Last Updated: 2016-02-17

Results Overview

Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to \<9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

627 participants

Primary outcome timeframe

Day 1 through Day 7 after each vaccination

Results posted on

2016-02-17

Participant Flow

Subjects were enrolled from 11 study centres in USA.

All enrolled subjects were included in the study.

Participant milestones

Participant milestones
Measure	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS Subjects 3 to \<9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS Subjects 3 to \<9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 3 TO <9 YEARS Subjects 3 to \<9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: ≥65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: ≥65 YEARS Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Overall Study STARTED	54	55	51	53	51	53	53	55	48	51	51	52
Overall Study COMPLETED	38	44	39	49	50	50	43	47	46	49	46	49
Overall Study NOT COMPLETED	16	11	12	4	1	3	10	8	2	2	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS Subjects 3 to \<9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS Subjects 3 to \<9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 3 TO <9 YEARS Subjects 3 to \<9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: ≥65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: ≥65 YEARS Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Overall Study Adverse Event	0	0	0	0	0	0	1	0	0	0	0	0
Overall Study Death	0	0	0	0	0	0	2	0	0	0	0	0
Overall Study Lost to Follow-up	11	10	7	3	0	3	4	7	2	0	0	2
Overall Study Other - Unclassified	1	1	1	0	0	0	2	1	0	0	1	0
Overall Study Withdrawal by Subject	4	0	4	1	1	0	1	0	0	2	4	1

Baseline Characteristics

Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to <65 Years and Elderly 65 Years and Older.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A/H3N2C + 1/2 MF59 : 3 TO <9 YEARS n=54 Participants Subjects 3 to \<9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 : 3 TO <9 YEARS n=55 Participants Subjects 3 to \<9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C : 3 TO <9 YEARS n=51 Participants Subjects 3 to \<9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 : 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 : 9 TO <18 YEARS n=51 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C : 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 : 18 TO <65 YEARS n=53 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 : 18 TO <65 YEARS n=55 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C : 18 TO <65 YEARS n=48 Participants Subjects 18 to \<65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 : ≥65 YEARS n=51 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 : ≥65 YEARS n=51 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C : ≥65 YEARS n=52 Participants Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	Total n=627 Participants Total of all reporting groups
Age, Continuous	6 YEARS STANDARD_DEVIATION 1.7 • n=5 Participants	6 YEARS STANDARD_DEVIATION 1.6 • n=7 Participants	6.2 YEARS STANDARD_DEVIATION 1.6 • n=5 Participants	12.6 YEARS STANDARD_DEVIATION 2.7 • n=4 Participants	12.8 YEARS STANDARD_DEVIATION 2.4 • n=21 Participants	12.3 YEARS STANDARD_DEVIATION 2.4 • n=10 Participants	42.3 YEARS STANDARD_DEVIATION 12.8 • n=115 Participants	42.4 YEARS STANDARD_DEVIATION 13.3 • n=6 Participants	44 YEARS STANDARD_DEVIATION 14.9 • n=6 Participants	71.3 YEARS STANDARD_DEVIATION 5.3 • n=64 Participants	72.9 YEARS STANDARD_DEVIATION 6.1 • n=17 Participants	73.8 YEARS STANDARD_DEVIATION 6.1 • n=21 Participants	33.2 YEARS STANDARD_DEVIATION 27.5 • n=22 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	27 Participants n=7 Participants	26 Participants n=5 Participants	29 Participants n=4 Participants	25 Participants n=21 Participants	26 Participants n=10 Participants	32 Participants n=115 Participants	25 Participants n=6 Participants	28 Participants n=6 Participants	31 Participants n=64 Participants	25 Participants n=17 Participants	32 Participants n=21 Participants	336 Participants n=22 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	28 Participants n=7 Participants	25 Participants n=5 Participants	24 Participants n=4 Participants	26 Participants n=21 Participants	27 Participants n=10 Participants	21 Participants n=115 Participants	30 Participants n=6 Participants	20 Participants n=6 Participants	20 Participants n=64 Participants	26 Participants n=17 Participants	20 Participants n=21 Participants	291 Participants n=22 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 7 after each vaccination

Population: Analysis was done on Solicited Safety Set.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=49 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=53 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=49 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. LOSS OF APPETITE (1st Vac.,N=32,27,32)	2 Number of Subjects	2 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. ANY- Vac. 1	31 Number of Subjects	36 Number of Subjects	18 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. ANY- Vac. 2 (N= 45,52,48)	24 Number of Subjects	25 Number of Subjects	22 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. INJECTION SITE REACTIONS- Vacc. 1	28 Number of Subjects	33 Number of Subjects	16 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. INJECTION SITE REACTIONS- Vacc. 2	22 Number of Subjects	24 Number of Subjects	17 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. ECCHYMOSIS (mm), < 6y (T.II, 1st Vac.,N=14,20,15)	2 Number of Subjects	0 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. ECCHYMOSIS (mm), < 6y (T.II, 2nd Vac.,N=11,21,16)	1 Number of Subjects	2 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,31)	0 Number of Subjects	0 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=32,31,32)	0 Number of Subjects	0 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. ERYTHEMA (mm), < 6y (T.II, 1st Vac.,N=14,20,16)	1 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,31)	2 Number of Subjects	0 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. ERYTHEMA (mm), < 6y (T.II, 2nd Vac.,N=12,21,16)	0 Number of Subjects	2 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=31,31,31)	2 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. INDURATION (mm), < 6y (T.II, 1st Vac.,N=14,20,16)	0 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. INDURATION (mm), < 6y (T.II, 2nd Vac.,N=12,21,16)	0 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,32)	2 Number of Subjects	3 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=32,31,31)	1 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. SYSTEMIC REACTIONS- Vacc. 1	15 Number of Subjects	19 Number of Subjects	7 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. SYSTEMIC REACTIONS- Vacc. 2	16 Number of Subjects	11 Number of Subjects	12 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. ARTHRALGIA (1st Vac.,N=31,27,30)	1 Number of Subjects	1 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. ARTHRALGIA (2nd Vac.,N=33,29,31)	1 Number of Subjects	0 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. BODY TEMPERATURE ≥38°C (1st Vac.,N=49,53,49)	0 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. BODY TEMPERATURE ≥38°C (2nd Vac.,N=42,52,48)	0 Number of Subjects	2 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. CHANGE IN EATING HABITS (1st Vac.,N=13,19,15)	1 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. CHANGE IN EATING HABITS (2nd Vac.,N=12,20,16)	1 Number of Subjects	3 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. DIARRHEA (1st Vac.,N=45,46,46)	0 Number of Subjects	3 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. DIARRHEA (2nd Vac.,N=43,50,46)	1 Number of Subjects	1 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. FATIGUE (1st Vac.,N=31,28,31)	5 Number of Subjects	9 Number of Subjects	4 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. FATIGUE (2nd Vac.,N=33,30,32)	5 Number of Subjects	1 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. HEADACHE (1st Vac.,N=32,28,31)	6 Number of Subjects	5 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. HEADACHE (2nd Vac.,N=33,31,32)	4 Number of Subjects	4 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. IRRITABILITY (1st Vac.,N=13,19,16)	2 Number of Subjects	2 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. IRRITABILITY (2nd Vac.,N=11,20,16)	3 Number of Subjects	3 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. LOSS OF APPETITE (2nd Vac.,N=32,30,30)	4 Number of Subjects	1 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. MALAISE (1st Vac.,N=32,28,32)	4 Number of Subjects	7 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. MALAISE (2nd Vac.,N=32,30,30)	6 Number of Subjects	4 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. MYALGIA (1st Vac.,N=32,28,32)	3 Number of Subjects	2 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. MYALGIA (2nd Vac.,N=33,31,32)	4 Number of Subjects	1 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. NAUSEA (1st Vac.,N=32,28,31)	5 Number of Subjects	2 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. NAUSEA (2nd Vac.,N=31,31,30)	3 Number of Subjects	2 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. PREV.OF PAIN/FEVER (1st Vac.,N=46,48,46)	0 Number of Subjects	1 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. PREV.OF PAIN/FEVER (2nd Vac.,N=44,51,47)	1 Number of Subjects	0 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. SLEEPINESS (1st Vac.,N=13,19,16)	2 Number of Subjects	2 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. SLEEPINESS (2nd Vac.,N=12,20,16)	1 Number of Subjects	3 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. TREAT.OF PAIN/FEVER (1st Vac.,N=46,49,46)	4 Number of Subjects	6 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. TREAT.OF PAIN/FEVER (2nd Vac.,N=44,51,47)	1 Number of Subjects	2 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. VOMITING (1st Vac.,N=46,47,48)	1 Number of Subjects	3 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. VOMITING (2nd Vac.,N=44,51,46)	2 Number of Subjects	2 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 through Day 7 after each vaccination

Population: Analysis was done on Solicited Safety Set.

Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to \<18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=54 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=51 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=53 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ANY- Vac. 1	37 Number of Subjects	40 Number of Subjects	35 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ANY- Vac. 2 (N=52,48,53)	30 Number of Subjects	24 Number of Subjects	27 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. INJECTION SITE REACTIONS- Vacc. 1	35 Number of Subjects	34 Number of Subjects	27 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. INJECTION SITE REACTIONS- Vacc. 2	24 Number of Subjects	20 Number of Subjects	23 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=53,51,53)	0 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ECCHYMOSIS (mm), ≥ 6y (T.II) (2nd Vac.,N=52,48,52)	0 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ERYTHEMA (mm), ≥ 6y (T.II) (1st Vac.,N=52,51,53)	0 Number of Subjects	3 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ERYTHEMA (mm), ≥ 6y (T.II) (2nd Vac.,N=51,48,52)	1 Number of Subjects	2 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. INDURATION (mm), ≥ 6y (T.II) (1st Vac.,N=52,51,53)	2 Number of Subjects	7 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. INDURATION (mm), ≥ 6y (T.II) (2nd Vac.,N=52,48,52)	3 Number of Subjects	4 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. SYSTEMIC REACTIONS- Vacc. 1	25 Number of Subjects	32 Number of Subjects	26 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. SYSTEMIC REACTIONS- Vacc. 2	17 Number of Subjects	14 Number of Subjects	15 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ARTHRALGIA (1st Vac.,N=51,50,51)	3 Number of Subjects	3 Number of Subjects	7 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ARTHRALGIA (2nd Vac.,N=49,48,52)	4 Number of Subjects	1 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. BODY TEMPERATURE >=38C (1st Vac.,N=53,51,53)	0 Number of Subjects	1 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. BODY TEMPERATURE ≥38°C (2nd Vac.,N=51,48,52)	0 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. DIARRHEA (1st Vac.,N=51,51,51)	3 Number of Subjects	5 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. DIARRHEA (2nd Vac.,N=50,47,49)	2 Number of Subjects	2 Number of Subjects	4 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. FATIGUE (1st Vac.,N=53,51,53)	12 Number of Subjects	16 Number of Subjects	18 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. FATIGUE (2nd Vac.,N=51,48,53)	9 Number of Subjects	12 Number of Subjects	9 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. HEADACHE (1st Vac.,N=53,50,53)	13 Number of Subjects	16 Number of Subjects	11 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. HEADACHE (2nd Vac.,N=50,48,53)	11 Number of Subjects	9 Number of Subjects	9 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. LOSS OF APPETITE (1st Vac.,N=53,51,51)	6 Number of Subjects	9 Number of Subjects	6 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. LOSS OF APPETITE (2nd Vac.,N=51,48,49)	5 Number of Subjects	4 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. MALAISE (1st Vac.,N=53,51,51)	10 Number of Subjects	12 Number of Subjects	10 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. MALAISE (2nd Vac.,N=51,48,49)	7 Number of Subjects	5 Number of Subjects	4 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. MYALGIA (1st Vac.,N=52,51,53)	6 Number of Subjects	9 Number of Subjects	5 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. MYALGIA (2nd Vac.,N=50,48,53)	5 Number of Subjects	2 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. NAUSEA (1st Vac.,N=53,51,53)	9 Number of Subjects	10 Number of Subjects	5 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. NAUSEA (2nd Vac.,N=50,48,53)	3 Number of Subjects	3 Number of Subjects	6 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. PREV.OF PAIN/FEVER (1st Vac.,N=54,49,52)	0 Number of Subjects	3 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. PREV.OF PAIN/FEVER (2nd Vac.,N=50,47,53)	0 Number of Subjects	1 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. TREAT.OF PAIN/FEVER (1st Vac.,N=54,50,52)	5 Number of Subjects	4 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. TREAT.OF PAIN/FEVER (2nd Vac.,N=49,47,53)	3 Number of Subjects	2 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. VOMITING (1st Vac.,N=53,51,51)	2 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. VOMITING (2nd Vac.,N=50,48,49)	1 Number of Subjects	0 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 through Day 7 after each vaccination

Population: Analysis was done on Solicited Safety Set.

Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to \< 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=51 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=54 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=48 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ANY- Vac. 1	30 Number of Subjects	40 Number of Subjects	27 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ANY- Vac. 2 (N=47,51,48)	21 Number of Subjects	28 Number of Subjects	21 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. INJECTION SITE REACTIONS- Vacc. 1	23 Number of Subjects	32 Number of Subjects	19 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. INJECTION SITE REACTIONS- Vacc. 2	17 Number of Subjects	24 Number of Subjects	15 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=50,52,45)	0 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=46,51,48)	0 Number of Subjects	0 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=50,53,47)	0 Number of Subjects	5 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=46,50,48)	0 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=50,53,46)	1 Number of Subjects	8 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=46,51,48)	1 Number of Subjects	2 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. SYSTEMIC REACTIONS- Vacc. 1	23 Number of Subjects	27 Number of Subjects	19 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. SYSTEMIC REACTIONS- Vacc. 2	15 Number of Subjects	20 Number of Subjects	13 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ARTHRALGIA (1st Vac.,N=50,51,45)	4 Number of Subjects	5 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ARTHRALGIA (2nd Vac.,N=46,48,48)	3 Number of Subjects	4 Number of Subjects	5 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. BODY TEMPERATURE ≥38°C (1st Vac.,N=51,54,47)	2 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. BODY TEMPERATURE ≥38°C (2nd Vac.,N=47,50,47)	0 Number of Subjects	0 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. DIARRHEA (1st Vac.,N=49,52,46)	6 Number of Subjects	10 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. DIARRHEA (2nd Vac.,N=44,50,47)	4 Number of Subjects	6 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. FATIGUE (1st Vac.,N=50,53,47)	10 Number of Subjects	11 Number of Subjects	8 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. FATIGUE (2nd Vac.,N=45,48,48)	7 Number of Subjects	8 Number of Subjects	7 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. HEADACHE (1st Vac.,N=51,53,47)	11 Number of Subjects	11 Number of Subjects	10 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. HEADACHE (2nd Vac.,N=47,49,48)	9 Number of Subjects	9 Number of Subjects	8 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. LOSS OF APPETITE (1st Vac.,N=50,53,47)	4 Number of Subjects	4 Number of Subjects	4 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. LOSS OF APPETITE (2nd Vac.,N=46,50,47)	0 Number of Subjects	4 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. MALAISE (1st Vac.,N=49,53,47)	12 Number of Subjects	12 Number of Subjects	4 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. MALAISE (2nd Vac.,N=45,50,47)	3 Number of Subjects	10 Number of Subjects	4 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. MYALGIA (1st Vac.,N=51,51,45)	7 Number of Subjects	7 Number of Subjects	6 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. MYALGIA (2nd Vac.,N=47,48,48)	2 Number of Subjects	5 Number of Subjects	4 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. NAUSEA (1st Vac.,N=50,52,47)	3 Number of Subjects	5 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. NAUSEA (2nd Vac.,N=47,50,47)	3 Number of Subjects	5 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. PREV.OF PAIN/FEVER (1st Vac.,N=49,52,48)	0 Number of Subjects	0 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. PREV.OF PAIN/FEVER (2nd Vac.,N=46,50,46)	0 Number of Subjects	1 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. TREAT.OF PAIN/FEVER (1st Vac.,N=49,53,48)	5 Number of Subjects	4 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. TREAT.OF PAIN /FEVER (2nd Vac.,N=46,50,46)	1 Number of Subjects	2 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. VOMITING (1st Vac.,N=49,53,47)	0 Number of Subjects	0 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. VOMITING (2nd Vac.,N=46,50,47)	0 Number of Subjects	1 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 through Day 7 after each vaccination

Population: Analysis was done on Solicited Safety Set.

Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=51 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=49 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=50 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ANY- Vac. 1	23 Number of Subjects	29 Number of Subjects	15 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ANY- Vac. 2 (N=51,45,48)	14 Number of Subjects	17 Number of Subjects	14 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. INJECTION SITE REACTIONS- Vac. 1	11 Number of Subjects	21 Number of Subjects	6 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. INJECTION SITE REACTIONS- Vac. 2	9 Number of Subjects	14 Number of Subjects	5 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=51,49,50)	2 Number of Subjects	0 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=49,45,48)	0 Number of Subjects	0 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=51,45,49)	1 Number of Subjects	1 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=49,44,48)	1 Number of Subjects	2 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=51,48,50)	1 Number of Subjects	2 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=49,44,48)	0 Number of Subjects	2 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. SYSTEMIC REACTIONS- Vacc. 1	17 Number of Subjects	16 Number of Subjects	13 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. SYSTEMIC REACTIONS- Vacc. 2	8 Number of Subjects	11 Number of Subjects	11 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ARTHRALGIA (1st Vac.,N=47,45,50)	3 Number of Subjects	4 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. ARTHRALGIA (2nd Vac.,N=50,43,47)	3 Number of Subjects	1 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. BODY TEMPERATURE ≥38°C (1st Vac.,N=51,48,50)	0 Number of Subjects	0 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. BODY TEMPERATURE ≥38°C (2nd Vac.,N=51,44,48)	0 Number of Subjects	0 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. DIARRHEA (1st Vac.,N=50,47,48)	5 Number of Subjects	3 Number of Subjects	4 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. DIARRHEA (2nd Vac.,N=49,44,44)	2 Number of Subjects	1 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. FATIGUE (1st Vac.,N=49,48,49)	8 Number of Subjects	8 Number of Subjects	4 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. FATIGUE (2nd Vac.,N=51,44,48)	5 Number of Subjects	6 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. HEADACHE (1st Vac.,N=50,49,50)	8 Number of Subjects	6 Number of Subjects	4 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. HEADACHE (2nd Vac.,N=51,44,48)	5 Number of Subjects	2 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. LOSS OF APPETITE (1st Vac.,N=50,48,49)	6 Number of Subjects	2 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. LOSS OF APPETITE (2nd Vac.,N=50,45,46)	3 Number of Subjects	1 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. MALAISE (1st Vac.,N=50,48,49)	5 Number of Subjects	6 Number of Subjects	2 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. MALAISE (2nd Vac.,N=50,45,46)	4 Number of Subjects	3 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. MYALGIA (1st Vac.,N=49,48,50)	4 Number of Subjects	5 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. MYALGIA (2nd Vac.,N=50,43,48)	2 Number of Subjects	1 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. NAUSEA (1st Vac.,N=51,49,50)	5 Number of Subjects	3 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. NAUSEA (2nd Vac.,N=50,45,47)	2 Number of Subjects	2 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. PREV.OF PAIN/FEVER (1st Vac.,N=48,46,50)	1 Number of Subjects	0 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. PREV.OF PAIN/FEVER (2nd Vac.,N=50,44,48)	0 Number of Subjects	0 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. TREAT.OF PAIN/FEVER (1st Vac.,N=48,46,50)	0 Number of Subjects	3 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. TREAT.OF PAIN/FEVER (2nd Vac.,N=50,44,48)	0 Number of Subjects	1 Number of Subjects	3 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. VOMITING (1st Vac.,N=51,48,49)	0 Number of Subjects	0 Number of Subjects	1 Number of Subjects	—	—	—	—	—	—	—	—	—
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. VOMITING (2nd Vac.,N=49,45,46)	0 Number of Subjects	0 Number of Subjects	0 Number of Subjects	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 through Day 366

Population: Analysis was done on unsolicited safety dataset i.e. all subjects in the exposed population who have post-vaccination unsolicited adverse event records.

The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported. The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=50 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=54 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=50 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS n=54 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS n=51 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS n=51 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS n=54 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS n=48 Participants Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS n=52 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS n=49 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS n=51 Participants Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. Any AE (Day 1 to Day 366)	0 Number of subjects	1 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	1 Number of subjects	3 Number of subjects	0 Number of subjects	1 Number of subjects	2 Number of subjects	5 Number of subjects	5 Number of subjects
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. At least possibly related AE	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. Any SAE	0 Number of subjects	1 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	1 Number of subjects	3 Number of subjects	0 Number of subjects	1 Number of subjects	2 Number of subjects	5 Number of subjects	5 Number of subjects
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. At least possibly related	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. AE leading to withdrawal	0 Number of subjects	1 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	3 Number of subjects	0 Number of subjects	0 Number of subjects	1 Number of subjects	3 Number of subjects	1 Number of subjects
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. Medically attended AEs	8 Number of subjects	21 Number of subjects	14 Number of subjects	13 Number of subjects	13 Number of subjects	20 Number of subjects	21 Number of subjects	17 Number of subjects	13 Number of subjects	31 Number of subjects	22 Number of subjects	23 Number of subjects
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. AESI	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. NOCD	0 Number of subjects	0 Number of subjects	1 Number of subjects	0 Number of subjects	2 Number of subjects	3 Number of subjects	0 Number of subjects	3 Number of subjects	1 Number of subjects	7 Number of subjects	1 Number of subjects	6 Number of subjects
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. Death	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	2 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects

PRIMARY outcome

Timeframe: Day 22, Day 43 post vaccination

Population: Analysis was done on Full Analysis Set.

The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported. Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer \<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=47 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=54 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=49 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS n=52 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS n=49 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS n=52 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS n=54 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS n=48 Participants Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS n=49 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS n=49 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS n=51 Participants Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51)	96 Percentages of Subjects Interval 85.5 to 99.5	98 Percentages of Subjects Interval 90.1 to 99.95	71 Percentages of Subjects Interval 56.7 to 83.4	88 Percentages of Subjects Interval 76.6 to 95.6	98 Percentages of Subjects Interval 88.9 to 99.95	85 Percentages of Subjects Interval 72.4 to 93.3	73 Percentages of Subjects Interval 59.0 to 84.4	89 Percentages of Subjects Interval 77.4 to 95.8	67 Percentages of Subjects Interval 51.6 to 79.6	57 Percentages of Subjects Interval 42.2 to 71.2	71 Percentages of Subjects Interval 56.7 to 83.4	61 Percentages of Subjects Interval 46.1 to 74.2
Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50)	100 Percentages of Subjects Interval 91.8 to 100.0	100 Percentages of Subjects Interval 93.3 to 100.0	92 Percentages of Subjects Interval 80.0 to 97.7	94 Percentages of Subjects Interval 84.1 to 98.8	98 Percentages of Subjects Interval 89.1 to 99.95	91 Percentages of Subjects Interval 79.3 to 96.9	82 Percentages of Subjects Interval 69.1 to 91.6	92 Percentages of Subjects Interval 81.5 to 97.9	71 Percentages of Subjects Interval 55.9 to 83.0	58 Percentages of Subjects Interval 43.2 to 72.4	80 Percentages of Subjects Interval 65.7 to 89.8	64 Percentages of Subjects Interval 49.2 to 77.1

PRIMARY outcome

Timeframe: Day 1, Day 22, Day 43 post vaccination

Population: Analysis was done on Full Analysis Set.

The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=53 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=55 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=50 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS n=51 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS n=53 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS n=55 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS n=48 Participants Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS n=50 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS n=50 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS n=52 Participants Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. Day 1	8 Percentages of Subjects Interval 2.1 to 18.2	7 Percentages of Subjects Interval 2.0 to 17.6	14 Percentages of Subjects Interval 5.8 to 26.7	45 Percentages of Subjects Interval 31.6 to 59.6	59 Percentages of Subjects Interval 44.2 to 72.4	49 Percentages of Subjects Interval 35.1 to 63.2	57 Percentages of Subjects Interval 42.3 to 70.2	67 Percentages of Subjects Interval 53.3 to 79.3	67 Percentages of Subjects Interval 51.6 to 79.6	56 Percentages of Subjects Interval 41.3 to 70.0	52 Percentages of Subjects Interval 37.4 to 66.3	46 Percentages of Subjects Interval 32.2 to 60.5
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51)	96 Percentages of Subjects Interval 85.5 to 99.5	98 Percentages of Subjects Interval 90.1 to 99.95	78 Percentages of Subjects Interval 63.4 to 88.2	100 Percentages of Subjects Interval 93.2 to 100.0	100 Percentages of Subjects Interval 92.6 to 100.0	98 Percentages of Subjects Interval 89.9 to 99.95	96 Percentages of Subjects Interval 86.8 to 99.53	100 Percentages of Subjects Interval 93.4 to 100.0	88 Percentages of Subjects Interval 74.8 to 95.3	94 Percentages of Subjects Interval 83.1 to 98.7	100 Percentages of Subjects Interval 92.7 to 100.0	96 Percentages of Subjects Interval 86.5 to 99.52
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50)	100 Percentages of Subjects Interval 91.8 to 100.0	100 Percentages of Subjects Interval 93.3 to 100.0	96 Percentages of Subjects Interval 85.7 to 99.5	100 Percentages of Subjects Interval 93.2 to 100.0	100 Percentages of Subjects Interval 92.7 to 100.0	100 Percentages of Subjects Interval 93.3 to 100.0	96 Percentages of Subjects Interval 86.5 to 99.52	100 Percentages of Subjects Interval 93.2 to 100.0	98 Percentages of Subjects Interval 88.9 to 99.95	98 Percentages of Subjects Interval 88.9 to 99.95	100 Percentages of Subjects Interval 92.7 to 100.0	96 Percentages of Subjects Interval 86.3 to 99.51

SECONDARY outcome

Timeframe: Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination

Population: Analysis was done on Full Analysis Set.

The HI antibody titers against H3N2 homologous strain at baseline (Day 1), three weeks after first (Day 22) and second (Day 43) vaccination and persisting titers at six months (Day 183) and one year (Day 366) after vaccination are reported in terms of GMTs is reported across subjects with age groups 3 to ≥ 65 years.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=53 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=55 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=50 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS n=51 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS n=53 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS n=55 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS n=48 Participants Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS n=50 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS n=50 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS n=52 Participants Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). Day 1	8.48 Titers Interval 6.89 to 10.0	8.26 Titers Interval 6.74 to 10.0	8.8 Titers Interval 7.1 to 11.0	28 Titers Interval 21.0 to 37.0	29 Titers Interval 22.0 to 39.0	27 Titers Interval 20.0 to 35.0	34 Titers Interval 26.0 to 44.0	52 Titers Interval 40.0 to 68.0	42 Titers Interval 32.0 to 56.0	36 Titers Interval 28.0 to 47.0	32 Titers Interval 25.0 to 42.0	26 Titers Interval 20.0 to 34.0
Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51)	192 Titers Interval 134.0 to 275.0	277 Titers Interval 198.0 to 387.0	93 Titers Interval 65.0 to 132.0	386 Titers Interval 293.0 to 510.0	456 Titers Interval 341.0 to 609.0	343 Titers Interval 261.0 to 452.0	300 Titers Interval 217.0 to 415.0	504 Titers Interval 367.0 to 692.0	226 Titers Interval 162.0 to 315.0	135 Titers Interval 103.0 to 177.0	206 Titers Interval 157.0 to 270.0	140 Titers Interval 107.0 to 183.0
Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50)	524 Titers Interval 396.0 to 694.0	679 Titers Interval 527.0 to 874.0	198 Titers Interval 152.0 to 258.0	486 Titers Interval 379.0 to 623.0	656 Titers Interval 508.0 to 849.0	389 Titers Interval 304.0 to 498.0	276 Titers Interval 208.0 to 365.0	427 Titers Interval 324.0 to 564.0	261 Titers Interval 196.0 to 347.0	131 Titers Interval 102.0 to 170.0	202 Titers Interval 157.0 to 261.0	163 Titers Interval 126.0 to 210.0
Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49)	97 Titers Interval 75.0 to 126.0	145 Titers Interval 113.0 to 185.0	67 Titers Interval 52.0 to 86.0	173 Titers Interval 137.0 to 218.0	242 Titers Interval 194.0 to 302.0	170 Titers Interval 135.0 to 214.0	161 Titers Interval 120.0 to 217.0	219 Titers Interval 166.0 to 289.0	188 Titers Interval 142.0 to 251.0	93 Titers Interval 72.0 to 121.0	122 Titers Interval 94.0 to 157.0	98 Titers Interval 76.0 to 126.0
Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49)	46 Titers Interval 35.0 to 61.0	70 Titers Interval 53.0 to 91.0	37 Titers Interval 28.0 to 49.0	112 Titers Interval 86.0 to 148.0	124 Titers Interval 96.0 to 161.0	111 Titers Interval 84.0 to 145.0	111 Titers Interval 84.0 to 148.0	170 Titers Interval 130.0 to 223.0	126 Titers Interval 96.0 to 165.0	55 Titers Interval 43.0 to 69.0	71 Titers Interval 56.0 to 91.0	68 Titers Interval 53.0 to 86.0

SECONDARY outcome

Timeframe: Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1

Population: Analysis was done on Full Analysis Set.

The geometric mean ratio (GMR) of post versus pre-vaccination HI antibody titers against H3N2 homologous strain following vaccination as compared to baseline titers are reported for after first (Day 22/Day 1) and second (Day 43/Day 1) vaccination and for persisting titers at six months (Day 183/Day1) and one year (Day 366/Day 1) is reported across subjects with age groups 3 to ≥ 65 years.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=47 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=54 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=49 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS n=52 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS n=48 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS n=52 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS n=54 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS n=48 Participants Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS n=49 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS n=49 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS n=51 Participants Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. Day22/Day1	22 Ratios Interval 15.0 to 32.0	33 Ratios Interval 23.0 to 47.0	11 Ratios Interval 7.51 to 16.0	14 Ratios Interval 9.58 to 19.0	15 Ratios Interval 10.0 to 22.0	13 Ratios Interval 8.91 to 18.0	7.54 Ratios Interval 5.41 to 11.0	11 Ratios Interval 8.16 to 16.0	5.35 Ratios Interval 3.8 to 7.55	3.79 Ratios Interval 2.71 to 5.29	6.64 Ratios Interval 4.75 to 9.28	5.13 Ratios Interval 3.7 to 7.13
Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49)	4.83 Ratios Interval 3.43 to 6.79	8.23 Ratios Interval 5.98 to 11.0	4.13 Ratios Interval 2.93 to 5.82	4.28 Ratios Interval 3.07 to 5.95	4.21 Ratios Interval 3.06 to 5.79	4.15 Ratios Interval 2.99 to 5.77	2.79 Ratios Interval 2.1 to 3.7	3.97 Ratios Interval 3.03 to 5.21	2.99 Ratios Interval 2.28 to 3.93	1.6 Ratios Interval 1.23 to 2.09	2.33 Ratios Interval 1.77 to 3.05	2.33 Ratios Interval 1.79 to 3.03
Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50)	59 Ratios Interval 43.0 to 81.0	82 Ratios Interval 62.0 to 109.0	23 Ratios Interval 17.0 to 31.0	18 Ratios Interval 13.0 to 25.0	21 Ratios Interval 15.0 to 30.0	14 Ratios Interval 10.0 to 20.0	7.16 Ratios Interval 5.34 to 9.61	9.58 Ratios Interval 7.17 to 13.0	6.24 Ratios Interval 4.62 to 8.44	3.82 Ratios Interval 2.8 to 5.21	6.55 Ratios Interval 4.81 to 8.91	5.94 Ratios Interval 4.38 to 8.07
Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49)	10 Ratios Interval 7.48 to 14.0	17 Ratios Interval 13.0 to 23.0	7.17 Ratios Interval 5.31 to 9.68	6.59 Ratios Interval 4.87 to 8.91	8.2 Ratios Interval 6.13 to 11.0	6.38 Ratios Interval 4.73 to 8.63	3.95 Ratios Interval 2.93 to 5.31	4.95 Ratios Interval 3.75 to 6.54	4.4 Ratios Interval 3.29 to 5.87	2.6 Ratios Interval 1.93 to 3.49	3.83 Ratios Interval 2.85 to 5.14	3.4 Ratios Interval 2.54 to 4.55

SECONDARY outcome

Timeframe: Day 183 and Day 366 post vaccination

Population: Analysis was done on the full analysis set.

The percentages of subjects (3 to ≥ 65 years of age) demonstrating HI titers ≥1:40 against H3N2 homologous strain on Day 183 and Day 366 post vaccination.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=39 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=44 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=42 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS n=47 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS n=50 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS n=47 Participants Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS n=45 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS n=50 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS n=46 Participants Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS n=48 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS n=48 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS n=49 Participants Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49)	95 Percentages of Subjects Interval 82.7 to 99.4	98 Percentages of Subjects Interval 88.0 to 99.94	81 Percentages of Subjects Interval 65.9 to 91.4	98 Percentages of Subjects Interval 88.7 to 99.95	100 Percentages of Subjects Interval 92.9 to 100.0	100 Percentages of Subjects Interval 92.5 to 100.0	87 Percentages of Subjects Interval 73.2 to 94.9	100 Percentages of Subjects Interval 92.9 to 100.0	87 Percentages of Subjects Interval 73.7 to 95.1	91 Percentages of Subjects Interval 79.6 to 97.6	94 Percentages of Subjects Interval 82.8 to 98.7	88 Percentages of Subjects Interval 75.2 to 95.4
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49)	82 Percentages of Subjects Interval 65.7 to 92.3	91 Percentages of Subjects Interval 77.9 to 97.4	58 Percentages of Subjects Interval 40.8 to 73.7	94 Percentages of Subjects Interval 82.5 to 98.7	98 Percentages of Subjects Interval 89.4 to 99.95	89 Percentages of Subjects Interval 76.9 to 96.5	81 Percentages of Subjects Interval 66.6 to 91.6	96 Percentages of Subjects Interval 85.5 to 99.5	80 Percentages of Subjects Interval 66.1 to 90.6	75 Percentages of Subjects Interval 60.4 to 86.4	80 Percentages of Subjects Interval 66.1 to 90.6	80 Percentages of Subjects Interval 65.7 to 89.8

SECONDARY outcome

Timeframe: Day 22, Day 43 post vaccination

Population: Analysis was done on Full Analysis Set.

The percentage of subjects achieving seroconversion or significant increase for HI antibody titers at three weeks after receiving first (Day 22) and second (Day 43) vaccination is reported, across age groups of 3 to ≥61 years. Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer \<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=46 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=54 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=49 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS n=48 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS n=47 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS n=48 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS n=39 Participants Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS n=54 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS n=55 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS n=60 Participants Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. Day 22	96 Percentages of Subjects Interval 85.2 to 99.5	98 Percentages of Subjects Interval 90.1 to 99.95	71 Percentages of Subjects Interval 56.7 to 83.4	89 Percentages of Subjects Interval 77.0 to 95.7	98 Percentages of Subjects Interval 88.9 to 99.95	85 Percentages of Subjects Interval 72.4 to 93.3	74 Percentages of Subjects Interval 59.7 to 86.1	90 Percentages of Subjects Interval 77.3 to 96.5	64 Percentages of Subjects Interval 47.2 to 78.8	57 Percentages of Subjects Interval 43.2 to 70.8	73 Percentages of Subjects Interval 59.0 to 83.9	63 Percentages of Subjects Interval 49.9 to 75.4
Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59)	100 Percentages of Subjects Interval 91.8 to 100.0	100 Percentages of Subjects Interval 93.3 to 100.0	92 Percentages of Subjects Interval 80.0 to 97.7	94 Percentages of Subjects Interval 84.1 to 98.8	98 Percentages of Subjects Interval 89.1 to 99.95	91 Percentages of Subjects Interval 79.3 to 96.9	85 Percentages of Subjects Interval 71.1 to 93.7	93 Percentages of Subjects Interval 82.1 to 98.6	67 Percentages of Subjects Interval 49.8 to 80.9	58 Percentages of Subjects Interval 44.1 to 71.9	80 Percentages of Subjects Interval 67.0 to 89.6	68 Percentages of Subjects Interval 54.4 to 79.4

SECONDARY outcome

Timeframe: Day 1, Day 22, Day 43 post vaccination

Population: Analysis was done on Full Analysis Set.

The percentages of subjects achieving HI titers ≥1:40 against H3N2 homologous strain at three weeks after receiving first (day 22) and second (day 43) vaccination, is reported across age groups of 3 to ≥ 61 years.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=52 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=55 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=50 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS n=54 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS n=51 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS n=48 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS n=49 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS n=39 Participants Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS n=55 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS n=56 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS n=61 Participants Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. Day 1	8 Percentages of Subjects Interval 2.1 to 18.5	7 Percentages of Subjects Interval 2.0 to 17.6	14 Percentages of Subjects Interval 5.8 to 26.7	44 Percentages of Subjects Interval 30.9 to 58.6	59 Percentages of Subjects Interval 44.2 to 72.4	49 Percentages of Subjects Interval 35.1 to 63.2	60 Percentages of Subjects Interval 45.3 to 74.2	67 Percentages of Subjects Interval 52.5 to 80.1	74 Percentages of Subjects Interval 57.9 to 87.0	53 Percentages of Subjects Interval 38.8 to 66.3	54 Percentages of Subjects Interval 39.7 to 67.0	44 Percentages of Subjects Interval 31.5 to 57.6
Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60)	96 Percentages of Subjects Interval 85.2 to 99.5	98 Percentages of Subjects Interval 90.1 to 99.95	78 Percentages of Subjects Interval 63.4 to 88.2	100 Percentages of Subjects Interval 93.3 to 100.0	100 Percentages of Subjects Interval 92.6 to 100.0	98 Percentages of Subjects Interval 89.9 to 99.95	98 Percentages of Subjects Interval 88.7 to 99.95	100 Percentages of Subjects Interval 92.6 to 100.0	90 Percentages of Subjects Interval 75.8 to 97.1	93 Percentages of Subjects Interval 82.1 to 97.9	100 Percentages of Subjects Interval 93.5 to 100.0	93 Percentages of Subjects Interval 83.8 to 98.2
Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59)	100 Percentages of Subjects Interval 91.8 to 100.0	100 Percentages of Subjects Interval 93.3 to 100.0	96 Percentages of Subjects Interval 85.7 to 99.5	100 Percentages of Subjects Interval 93.2 to 100.0	100 Percentages of Subjects Interval 92.7 to 100.0	100 Percentages of Subjects Interval 93.3 to 100.0	98 Percentages of Subjects Interval 88.5 to 99.94	100 Percentages of Subjects Interval 92.3 to 100.0	100 Percentages of Subjects Interval 91.0 to 100.0	96 Percentages of Subjects Interval 87.0 to 99.54	100 Percentages of Subjects Interval 93.5 to 100.0	95 Percentages of Subjects Interval 85.9 to 98.9

SECONDARY outcome

Timeframe: Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1

Population: Analysis was done on Full Analysis Set.

GMR of post-vaccination versus pre-vaccination HI GMTs following vaccination with H3N2 monovalent vaccine is reported across subjects with age groups 3 to ≥ 61 years.

Outcome measures

Outcome measures
Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n=46 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n=54 Participants Subjects, 3 to \< 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.	A/H3N2C - Age Group: 3 TO <9 YEARS n=49 Participants Subjects, 3 to \< 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS n=50 Participants Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS n=53 Participants Subjects 9 to \<18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS n=47 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS n=48 Participants Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS n=39 Participants Subjects 18 to \<65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS n=54 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS n=55 Participants Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS n=60 Participants Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60)	22 Ratios Interval 15.0 to 32.0	33 Ratios Interval 23.0 to 47.0	11 Ratios Interval 7.5 to 16.0	14 Ratios Interval 9.76 to 19.0	15 Ratios Interval 10.0 to 22.0	13 Ratios Interval 8.91 to 18.0	7.8 Ratios Interval 5.48 to 11.0	12 Ratios Interval 8.62 to 17.0	4.93 Ratios Interval 3.35 to 7.25	4.05 Ratios Interval 2.93 to 5.59	6.73 Ratios Interval 4.88 to 9.28	5.53 Ratios Interval 4.07 to 7.52
GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59)	59 Ratios Interval 43.0 to 81.0	82 Ratios Interval 62.0 to 109.0	23 Ratios Interval 17.0 to 31.0	18 Ratios Interval 13.0 to 25.0	21 Ratios Interval 15.0 to 30.0	14 Ratios Interval 10.0 to 20.0	7.1 Ratios Interval 5.21 to 9.69	10 Ratios Interval 7.61 to 14.0	6.04 Ratios Interval 4.32 to 8.45	4.14 Ratios Interval 3.07 to 5.56	6.57 Ratios Interval 4.9 to 8.8	6.2 Ratios Interval 4.68 to 8.22
GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58	9.96 Ratios Interval 7.25 to 14.0	17 Ratios Interval 13.0 to 23.0	7.18 Ratios Interval 5.32 to 9.7	6.76 Ratios Interval 5.02 to 9.1	8.19 Ratios Interval 6.12 to 11.0	6.38 Ratios Interval 4.72 to 8.62	3.98 Ratios Interval 2.87 to 5.51	5.23 Ratios Interval 3.86 to 7.09	4.30 Ratios Interval 3.08 to 6.0	2.69 Ratios Interval 2.03 to 3.55	3.82 Ratios Interval 2.9 to 5.03	3.56 Ratios Interval 2.73 to 4.65
GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58	4.55 Ratios Interval 3.22 to 6.42	8.26 Ratios Interval 6.02 to 11.0	4.09 Ratios Interval 2.91 to 5.75	4.43 Ratios Interval 3.2 to 6.14	4.20 Ratios Interval 3.06 to 5.78	4.15 Ratios Interval 2.98 to 5.77	2.73 Ratios Interval 2.0 to 3.73	4.21 Ratios Interval 3.13 to 5.67	3.03 Ratios Interval 2.22 to 4.14	1.69 Ratios Interval 1.32 to 2.18	2.35 Ratios Interval 1.82 to 3.04	2.37 Ratios Interval 1.86 to 3.01

Adverse Events

A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

A/H3N2C + MF59 Age Group: 3 TO <9 YEARS

Serious events: 1 serious events

Other events: 46 other events

Deaths: 0 deaths

A/H3N2C Age Group: 3 TO <9 YEARS

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

A/H3N2C + MF59 Age Group: 9 TO <18 YEARS

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

A/H3N2C Age Group: 9 TO <18 YEARS

Serious events: 1 serious events

Other events: 45 other events

Deaths: 0 deaths

A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS

Serious events: 3 serious events

Other events: 35 other events

Deaths: 0 deaths

A/H3N2C + MF59 Age Group: 18 TO <65 YEARS

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

A/H3N2C Age Group: 18 TO <65 YEARS

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

A/H3N2C + MF59 Age Group: >=65 YEARS

Serious events: 5 serious events

Other events: 31 other events

Deaths: 0 deaths

A/H3N2C Age Group: >=65 YEARS

Serious events: 5 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS n=50 participants at risk Subjects 3 to \<9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS n=54 participants at risk Subjects 3 to \<9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 3 TO <9 YEARS n=50 participants at risk Subjects 3 to \<9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS n=54 participants at risk Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS n=51 participants at risk Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS n=53 participants at risk Subjects 9 to \<18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS n=51 participants at risk Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS n=54 participants at risk Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS n=48 participants at risk Subjects 18 to \<65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS n=52 participants at risk Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS n=49 participants at risk Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS n=51 participants at risk Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Cardiac disorders CORONARY ARTERY THROMBOSIS	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Gastrointestinal disorders GASTRIC ULCER HAEMORRHAGE	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
General disorders SURGICAL FAILURE	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Infections and infestations APPENDICITIS	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.1% 1/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Infections and infestations PNEUMONIA	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Infections and infestations SEPSIS	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Injury, poisoning and procedural complications HEAD INJURY	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Injury, poisoning and procedural complications OVERDOSE	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Injury, poisoning and procedural complications TOXICITY TO VARIOUS AGENTS	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Investigations HEPATIC ENZYME INCREASED	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA METASTATIC	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Psychiatric disorders DEPRESSION	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Vascular disorders AORTIC RUPTURE	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Vascular disorders ARTERIOSCLEROSIS	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.

Other adverse events

Other adverse events
Measure	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS n=50 participants at risk Subjects 3 to \<9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS n=54 participants at risk Subjects 3 to \<9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 3 TO <9 YEARS n=50 participants at risk Subjects 3 to \<9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS n=54 participants at risk Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS n=51 participants at risk Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 9 TO <18 YEARS n=53 participants at risk Subjects 9 to \<18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS n=51 participants at risk Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS n=54 participants at risk Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: 18 TO <65 YEARS n=48 participants at risk Subjects 18 to \<65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS n=52 participants at risk Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	A/H3N2C + MF59 Age Group: >=65 YEARS n=49 participants at risk Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	A/H3N2C Age Group: >=65 YEARS n=51 participants at risk Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
General disorders INJECTION SITE ERYTHEMA	8.0% 4/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.3% 5/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	7.8% 4/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.8% 2/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	13.0% 7/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.1% 1/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	7.7% 4/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	6.1% 3/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	7.8% 4/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Gastrointestinal disorders DIARRHOEA	2.0% 1/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.3% 5/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.3% 5/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.8% 5/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	11.3% 6/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	15.7% 8/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	27.8% 15/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	8.3% 4/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	13.5% 7/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	8.2% 4/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.8% 5/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Gastrointestinal disorders NAUSEA	12.0% 6/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.3% 5/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	22.2% 12/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	21.6% 11/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	18.9% 10/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.8% 5/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	20.4% 11/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	10.4% 5/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	11.5% 6/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	12.2% 6/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.8% 5/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Gastrointestinal disorders VOMITING	8.0% 4/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	7.4% 4/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	6.0% 3/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	7.4% 4/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	6.2% 3/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.9% 2/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
General disorders FATIGUE	14.0% 7/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	20.4% 11/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	14.0% 7/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	33.3% 18/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	41.2% 21/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	35.8% 19/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	23.5% 12/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	33.3% 18/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	22.9% 11/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	21.2% 11/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	26.5% 13/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	13.7% 7/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
General disorders INJECTION SITE BRUISING	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.7% 2/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	6.0% 3/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.9% 2/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	4.2% 2/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.8% 2/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.9% 3/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
General disorders INJECTION SITE HAEMORRHAGE	6.0% 3/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.7% 2/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.9% 2/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.1% 1/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.8% 2/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
General disorders INJECTION SITE INDURATION	8.0% 4/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	13.0% 7/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.6% 3/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	17.6% 9/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.7% 3/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	16.7% 9/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.1% 1/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.8% 2/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	4.1% 2/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.9% 3/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
General disorders INJECTION SITE PAIN	62.0% 31/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	70.4% 38/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	46.0% 23/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	72.2% 39/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	72.5% 37/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	62.3% 33/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	51.0% 26/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	64.8% 35/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	45.8% 22/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	28.8% 15/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	46.9% 23/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	13.7% 7/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
General disorders MALAISE	18.0% 9/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	20.4% 11/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	6.0% 3/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	24.1% 13/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	29.4% 15/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	20.8% 11/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	25.5% 13/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	35.2% 19/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	12.5% 6/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	17.3% 9/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	12.2% 6/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.9% 3/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
General disorders PYREXIA	6.0% 3/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.3% 5/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.9% 3/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.8% 2/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.9% 2/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.1% 1/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Infections and infestations NASOPHARYNGITIS	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.7% 2/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	8.0% 4/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.7% 2/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Infections and infestations PHARYNGITIS	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.7% 2/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	7.5% 4/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Infections and infestations PHARYNGITIS STREPTOCOCCAL	2.0% 1/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.3% 5/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	4.0% 2/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.9% 2/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.8% 2/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.1% 1/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Infections and infestations SINUSITIS	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	4.0% 2/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.8% 2/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.6% 3/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.8% 2/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	4.0% 2/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.8% 5/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Metabolism and nutrition disorders DECREASED APPETITE	12.0% 6/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.6% 3/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	4.0% 2/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	18.5% 10/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	23.5% 12/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	13.2% 7/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	7.8% 4/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	13.0% 7/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	8.3% 4/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	15.4% 8/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	6.1% 3/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.9% 2/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Musculoskeletal and connective tissue disorders ARTHRALGIA	4.0% 2/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.3% 5/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.8% 5/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	18.9% 10/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	11.8% 6/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	16.7% 9/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	16.7% 8/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	13.5% 7/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	10.2% 5/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.8% 5/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Musculoskeletal and connective tissue disorders MYALGIA	12.0% 6/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.6% 3/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	4.0% 2/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	18.5% 10/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	19.6% 10/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	11.3% 6/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	15.7% 8/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	20.4% 11/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	18.8% 9/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.6% 5/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	12.2% 6/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	9.8% 5/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Nervous system disorders HEADACHE	16.0% 8/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	13.0% 7/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	8.0% 4/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	35.2% 19/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	37.3% 19/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	28.3% 15/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	29.4% 15/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	33.3% 18/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	27.1% 13/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	17.3% 9/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	16.3% 8/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	11.8% 6/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Nervous system disorders SOMNOLENCE	6.0% 3/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	7.4% 4/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	4.0% 2/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Psychiatric disorders EATING DISORDER	2.0% 1/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.6% 3/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Psychiatric disorders IRRITABILITY	6.0% 3/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	7.4% 4/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	8.0% 4/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	6.0% 3/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.9% 2/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.9% 2/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.7% 3/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.7% 3/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	7.8% 4/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.9% 2/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Skin and subcutaneous tissue disorders RASH	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.9% 3/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	3.8% 2/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.
Vascular disorders HYPERTENSION	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/50 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	2.0% 1/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/53 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.6% 3/54 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/48 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	1.9% 1/52 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	0.00% 0/49 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.	5.9% 3/51 • Day 1 through Day 366. All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; any unsolicited AEs, any SAEs, medically attended AEs, AEs leading to withdrawal from the study, AESI and NOCD were collected from Day 1 (from 30 minutes) to Day 366 after every vaccination. Analysis was done on the safety data sets.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER