Trial Outcomes & Findings for A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA (NCT NCT00958126)

NCT ID: NCT00958126

Last Updated: 2017-11-21

Results Overview

Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1313 participants
• Primary outcome timeframe: 21 days after the first vaccination
• Results posted on: 2017-11-21

Participant Flow

Participant milestones

Measure	Placebo, Adults Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Overall Study STARTED	49	205	201	203	50	203	200	202
Overall Study COMPLETED	48	196	191	192	50	202	199	202
Overall Study NOT COMPLETED	1	9	10	11	0	1	1	0

Reasons for withdrawal

Measure	Placebo, Adults Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Overall Study Serious Adverse Event	0	2	0	0	0	0	1	0
Overall Study Withdrawal by Subject	0	2	0	0	0	0	0	0
Overall Study Moved away from study area	0	0	1	1	0	0	0	0
Overall Study Lost to Follow-up	1	5	9	8	0	0	0	0
Overall Study Sponsor/Investigator decision	0	0	0	1	0	0	0	0
Overall Study Other Reason	0	0	0	1	0	1	0	0

Baseline Characteristics

A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA

Baseline characteristics by cohort

Measure	Placebo, Adults n=49 Participants Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults n=205 Participants 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults n=201 Participants 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults n=203 Participants 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults n=50 Participants Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults n=203 Participants 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults n=200 Participants 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults n=202 Participants 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	Total n=1313 Participants Total of all reporting groups
Age, Customized >= 18 years to 64 years	49 participants n=5 Participants	205 participants n=7 Participants	201 participants n=5 Participants	203 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	0 participants n=115 Participants	0 participants n=6 Participants	658 participants n=6 Participants
Age, Customized >=65 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	50 participants n=21 Participants	203 participants n=10 Participants	200 participants n=115 Participants	202 participants n=6 Participants	655 participants n=6 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	123 Participants n=7 Participants	113 Participants n=5 Participants	113 Participants n=4 Participants	29 Participants n=21 Participants	120 Participants n=10 Participants	108 Participants n=115 Participants	112 Participants n=6 Participants	749 Participants n=6 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	82 Participants n=7 Participants	88 Participants n=5 Participants	90 Participants n=4 Participants	21 Participants n=21 Participants	83 Participants n=10 Participants	92 Participants n=115 Participants	90 Participants n=6 Participants	564 Participants n=6 Participants

PRIMARY outcome

Timeframe: 21 days after the first vaccination

Population: The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).

Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.

Outcome measures

Measure	Placebo, Adults n=48 Participants Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults n=200 Participants 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults n=195 Participants 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults n=199 Participants 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults n=48 Participants Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults n=201 Participants 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults n=197 Participants 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults n=200 Participants 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Seroconversion Rate 21 Days After the First Vaccination	0 percentage of participants Interval 0.0 to 7.4	82 percentage of participants Interval 76.0 to 87.1	88.2 percentage of participants Interval 82.8 to 92.4	94.5 percentage of participants Interval 90.3 to 97.2	2.1 percentage of participants Interval 0.1 to 11.1	51.2 percentage of participants Interval 44.1 to 58.3	58.9 percentage of participants Interval 51.7 to 65.8	73.0 percentage of participants Interval 66.3 to 79.0

PRIMARY outcome

Timeframe: 21 days after the second vaccination

Population: The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).

Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.

Outcome measures

Measure	Placebo, Adults n=48 Participants Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults n=196 Participants 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults n=191 Participants 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults n=193 Participants 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults n=48 Participants Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults n=200 Participants 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults n=196 Participants 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults n=198 Participants 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Seroconversion Rate 21 Days After the Second Vaccination	6.3 percentage of participants Interval 1.3 to 17.2	83.2 percentage of participants Interval 77.2 to 88.1	91.1 percentage of participants Interval 86.1 to 94.7	95.9 percentage of participants Interval 92.0 to 98.2	8.3 percentage of participants Interval 2.3 to 20.0	59.5 percentage of participants Interval 52.3 to 66.4	67.3 percentage of participants Interval 60.3 to 73.9	75.3 percentage of participants Interval 68.6 to 81.1

PRIMARY outcome

Timeframe: 21 days after the first vaccination

Population: The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).

Outcome measures

Measure	Placebo, Adults n=48 Participants Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults n=200 Participants 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults n=195 Participants 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults n=199 Participants 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults n=48 Participants Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults n=201 Participants 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults n=197 Participants 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults n=200 Participants 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination	22.9 percentage of participants Interval 12.0 to 37.3	97.0 percentage of participants Interval 93.6 to 98.9	96.4 percentage of participants Interval 92.7 to 98.5	99.5 percentage of participants Interval 97.2 to 100.0	39.6 percentage of participants Interval 25.8 to 54.7	92.0 percentage of participants Interval 87.4 to 95.4	90.9 percentage of participants Interval 85.9 to 94.5	94.0 percentage of participants Interval 89.8 to 96.9

PRIMARY outcome

Timeframe: 21 days after the second vaccination

Population: The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).

Outcome measures

Measure	Placebo, Adults n=48 Participants Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults n=196 Participants 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults n=191 Participants 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults n=193 Participants 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults n=48 Participants Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults n=200 Participants 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults n=196 Participants 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults n=198 Participants 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination	29.2 percentage of participants Interval 17.0 to 44.1	98.5 percentage of participants Interval 95.6 to 99.7	99.5 percentage of participants Interval 97.1 to 100.0	99.5 percentage of participants Interval 97.1 to 100.0	35.4 percentage of participants Interval 22.2 to 50.5	96.0 percentage of participants Interval 92.3 to 98.3	93.4 percentage of participants Interval 88.9 to 96.4	94.9 percentage of participants Interval 90.9 to 97.6

SECONDARY outcome

Timeframe: During the 7 days after the first vaccination

Population: The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.

Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.

Outcome measures

Measure	Placebo, Adults n=49 Participants Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults n=204 Participants 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults n=201 Participants 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults n=203 Participants 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults n=50 Participants Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults n=203 Participants 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults n=200 Participants 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults n=202 Participants 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Grade 3 swelling/induration at injection site	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any tenderness at injection site	18.4 percentage of participants	23.5 percentage of participants	32.8 percentage of participants	46.8 percentage of participants	4.0 percentage of participants	10.3 percentage of participants	20.0 percentage of participants	18.3 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Grade 3 tenderness at injection site	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Grade 3 bruising at injection site	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Grade 3 myalgia	0 percentage of participants	0.5 percentage of participants	0.5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any local solicited adverse event	22.4 percentage of participants Interval 11.8 to 36.6	28.9 percentage of participants Interval 22.8 to 35.7	35.8 percentage of participants Interval 29.2 to 42.9	52.7 percentage of participants Interval 45.6 to 59.7	4.0 percentage of participants	13.3 percentage of participants	23.5 percentage of participants	21.8 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any pain at injection site	14.3 percentage of participants Interval 5.9 to 27.2	14.7 percentage of participants Interval 10.1 to 20.3	17.4 percentage of participants Interval 12.4 to 23.4	31.0 percentage of participants Interval 24.7 to 37.9	2.0 percentage of participants	2.0 percentage of participants	4.0 percentage of participants	6.9 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Grade 3 pain at injection site	0 percentage of participants	0 percentage of participants	0 percentage of participants	0.5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any redness at injection site	0 percentage of participants	1.0 percentage of participants	0.5 percentage of participants	1.0 percentage of participants	0 percentage of participants	0.5 percentage of participants	1.0 percentage of participants	0 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Grade 3 redness at injection site	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any swelling/induration at injection site	0 percentage of participants	3.9 percentage of participants	2.5 percentage of participants	3.9 percentage of participants	0 percentage of participants	2.0 percentage of participants	3.0 percentage of participants	2.5 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any bruising at injection site	0 percentage of participants	4.4 percentage of participants	4.0 percentage of participants	1.0 percentage of participants	0 percentage of participants	1.5 percentage of participants	3.0 percentage of participants	1.5 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any solicited systemic adverse event	28.6 percentage of participants	35.3 percentage of participants	34.8 percentage of participants	40.9 percentage of participants	18.0 percentage of participants	16.7 percentage of participants	24.0 percentage of participants	22.8 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any headache	16.3 percentage of participants	19.6 percentage of participants	21.4 percentage of participants	27.1 percentage of participants	8.0 percentage of participants	9.4 percentage of participants	10.5 percentage of participants	10.4 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Grade 3 headache	0 percentage of participants	1.0 percentage of participants	1.0 percentage of participants	0 percentage of participants	0 percentage of participants	0.5 percentage of participants	0 percentage of participants	0.5 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any malaise	8.2 percentage of participants	10.8 percentage of participants	16.4 percentage of participants	17.2 percentage of participants	10.0 percentage of participants	5.4 percentage of participants	9.5 percentage of participants	11.9 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Grade 3 malaise	0 percentage of participants	1.0 percentage of participants	1.0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any myalgia	4.1 percentage of participants	14.7 percentage of participants	15.9 percentage of participants	17.7 percentage of participants	8.0 percentage of participants	8.9 percentage of participants	13.0 percentage of participants	13.4 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any nausea	4.1 percentage of participants	6.4 percentage of participants	8.0 percentage of participants	7.9 percentage of participants	2.0 percentage of participants	1.0 percentage of participants	2.5 percentage of participants	3.5 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Grade 3 nausea	0 percentage of participants	0.5 percentage of participants	0 percentage of participants	0.5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any chills	2.0 percentage of participants	3.9 percentage of participants	5.0 percentage of participants	5.4 percentage of participants	0 percentage of participants	0.5 percentage of participants	1.0 percentage of participants	3.0 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Grade 3 chills	0 percentage of participants	0.5 percentage of participants	0.5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any vomiting	0 percentage of participants	2.9 percentage of participants	1.0 percentage of participants	1.0 percentage of participants	0 percentage of participants	0 percentage of participants	0.5 percentage of participants	0.5 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Grade 3 vomiting	0 percentage of participants	0.5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Any fever	2.0 percentage of participants	3.4 percentage of participants	3.0 percentage of participants	3.4 percentage of participants	0 percentage of participants	0 percentage of participants	0.5 percentage of participants	0.5 percentage of participants
Frequency and Intensity of Solicited Adverse Events After the First Vaccination Grade 3 fever	0 percentage of participants	0.5 percentage of participants	1.0 percentage of participants	0.5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs

Population: The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.

Outcome measures

Measure	Placebo, Adults n=49 Participants Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults n=204 Participants 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults n=201 Participants 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults n=203 Participants 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults n=50 Participants Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults n=203 Participants 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults n=200 Participants 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults n=202 Participants 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Duration of Solicited Local Adverse Events After the First Vaccination Swelling/induration at injection site	NA days Standard Deviation NA n = 0	1.56 days Standard Deviation 0.726	1.2 days Standard Deviation 0.447	3.38 days Standard Deviation 2.615	NA days Standard Deviation NA n = 0	6.00 days Standard Deviation 10.00	1.5 days Standard Deviation 0.837	3.2 days Standard Deviation 4.382
Duration of Solicited Local Adverse Events After the First Vaccination Pain at injection site	1.14 days Standard Deviation 0.378	1.87 days Standard Deviation 2.705	1.71 days Standard Deviation 0.926	1.91 days Standard Deviation 1.237	1.00 days Standard Deviation NA n = 1	1.75 days Standard Deviation 0.957	1.75 days Standard Deviation 0.886	1.27 days Standard Deviation 0.594
Duration of Solicited Local Adverse Events After the First Vaccination Redness at injection site	NA days Standard Deviation NA n = 0	1.00 days Standard Deviation 0.000	1.00 days Standard Deviation NA n = 1	2.50 days Standard Deviation 0.707	NA days Standard Deviation NA n = 0	1.00 days Standard Deviation NA n = 1	1.00 days Standard Deviation 0.000	NA days Standard Deviation NA n = 0
Duration of Solicited Local Adverse Events After the First Vaccination Tenderness at injection site	2.1 days Standard Deviation 1.912	2.04 days Standard Deviation 2.813	1.85 days Standard Deviation 0.966	1.90 days Standard Deviation 1.082	1.5 days Standard Deviation 0.707	1.27 days Standard Deviation 0.550	1.71 days Standard Deviation 0.955	1.65 days Standard Deviation 1.075
Duration of Solicited Local Adverse Events After the First Vaccination Bruising at injection site	NA days Standard Deviation NA n = 0	3.00 days Standard Deviation 2.539	2.25 days Standard Deviation 1.669	2.00 days Standard Deviation 0.000	NA days Standard Deviation NA n = 0	8.00 days Standard Deviation 11.269	4.33 days Standard Deviation 2.503	1.20 days Standard Deviation 0.447

SECONDARY outcome

Timeframe: Up to 180 days after the last vaccination

Population: The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.

A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).

Outcome measures

Measure	Placebo, Adults n=49 Participants Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults n=204 Participants 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults n=201 Participants 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults n=203 Participants 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults n=50 Participants Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults n=203 Participants 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults n=200 Participants 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults n=202 Participants 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) Percentage of participants with related AESI	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) Percentage of participants with at least one SAE	0 percentage of participants	2.9 percentage of participants	2.0 percentage of participants	1.5 percentage of participants	6.0 percentage of participants	4.4 percentage of participants	3.0 percentage of participants	4.5 percentage of participants
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) Percentage of participants with related SAE	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) Percentage of participants with at least one AESI	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) Percentage of participants with at least one NOCI	4.1 percentage of participants	0.5 percentage of participants	0.5 percentage of participants	0.5 percentage of participants	2.0 percentage of participants	1.0 percentage of participants	2.5 percentage of participants	2.0 percentage of participants
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) Percentage of participants with related NOCI	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI

Population: The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.

Unsolicited adverse event (UAE) grading:

Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.

Grade 2 (moderate): Enough discomfort to cause some interference with daily activities.

Grade 3 (severe): Symptoms that prevented normal, everyday activities.

Outcome measures

Measure	Placebo, Adults n=99 Participants Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults n=407 Participants 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults n=401 Participants 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults n=405 Participants 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination Percentage of participants reporting Grade 3 UAE	5.1 percentage of participants	5.9 percentage of participants	6.2 percentage of participants	4.7 percentage of participants	—	—	—	—
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination Percentage of participants with at least one UAE	27.3 percentage of participants	27.5 percentage of participants	30.2 percentage of participants	27.9 percentage of participants	—	—	—	—
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination Percentage of participants reporting Grade 1 UAE	7.1 percentage of participants	12.8 percentage of participants	10.0 percentage of participants	12.8 percentage of participants	—	—	—	—
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination Percentage of participants reporting Grade 2 UAE	15.2 percentage of participants	8.8 percentage of participants	14.0 percentage of participants	10.4 percentage of participants	—	—	—	—

Adverse Events

Placebo, Adults

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

CSL425 (7.5 mcg), Adults

Serious events: 6 serious events

Other events: 27 other events

Deaths: 0 deaths

CSL425 (15 Mcg), Adults

Serious events: 4 serious events

Other events: 25 other events

Deaths: 0 deaths

CSL425 (30 Mcg), Adults

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo, Older Adults

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

CSL425 (7.5 Mcg), Older Adults

Serious events: 9 serious events

Other events: 20 other events

Deaths: 0 deaths

CSL425 (15 Mcg), Older Adults

Serious events: 6 serious events

Other events: 23 other events

Deaths: 0 deaths

CSL425 (30 Mcg), Older Adults

Serious events: 9 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo, Adults n=49 participants at risk Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults n=204 participants at risk 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults n=201 participants at risk 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults n=203 participants at risk 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults n=50 participants at risk Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults n=203 participants at risk 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults n=200 participants at risk 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults n=202 participants at risk 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Infections and infestations Pneumonia	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/201 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 1/50 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Infections and infestations Appendicitis	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Infections and infestations Cellulitis	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/202 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Infections and infestations Subcutaneous abscess	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Infections and infestations Viral infection	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/201 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Blood and lymphatic system disorders Anaemia	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/201 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Cardiac disorders Myocardial infarction	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/201 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Gastrointestinal disorders Umbilical hernia, obstructive	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Renal and urinary disorders Urinary retention	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Congenital, familial and genetic disorders Fibrous dysplasia of bone	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/201 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Infections and infestations Acute sinusitis	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Infections and infestations Arthritis bacterial	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Infections and infestations Viral myocarditis	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung metastatic cancer	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Nervous system disorders Presyncope	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Cardiac disorders Atrial fibrillation	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	1.0% 2/200 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Cardiac disorders Acute myocardial infarction	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Cardiac disorders Cardiac failure	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Cardiac disorders Pericarditis	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 1/50 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Cardiac disorders Ventricular fibrillation	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Musculoskeletal and connective tissue disorders Athralgia	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 1/50 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Reproductive system and breast disorders Prostatic obstruction	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Injury, poisoning and procedural complications Arterial injury	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.

Other adverse events

Measure	Placebo, Adults n=49 participants at risk Vaccine diluent; Adults aged 18 to 64 years	CSL425 (7.5 mcg), Adults n=204 participants at risk 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (15 Mcg), Adults n=201 participants at risk 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	CSL425 (30 Mcg), Adults n=203 participants at risk 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years	Placebo, Older Adults n=50 participants at risk Vaccine diluent; Older adults aged 65 years or older	CSL425 (7.5 Mcg), Older Adults n=203 participants at risk 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (15 Mcg), Older Adults n=200 participants at risk 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older	CSL425 (30 Mcg), Older Adults n=202 participants at risk 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Infections and infestations Nasopharyngitis	4.1% 2/49 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 4/204 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 4/201 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	1.5% 3/203 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/202 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Infections and infestations Oral herpes	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.98% 2/204 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/201 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Infections and infestations Rhinitis	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/203 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Infections and infestations Pneumonia	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Infections and infestations Urinary tract infection	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/203 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Psychiatric disorders Anxiety	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Psychiatric disorders Insomnia	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Psychiatric disorders Depression	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Nervous system disorders Headache	4.1% 2/49 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	3.9% 8/204 • Number of events 8 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.5% 5/201 • Number of events 7 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 4/203 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	3.4% 7/203 • Number of events 8 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	1.5% 3/200 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/202 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Vascular disorders Hypertension	4.1% 2/49 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/201 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.9% 6/204 • Number of events 6 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	4.0% 8/201 • Number of events 8 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	3.9% 8/203 • Number of events 8 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	1.0% 2/200 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.5% 5/204 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	3.5% 7/201 • Number of events 7 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	4.4% 9/203 • Number of events 9 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	1.5% 3/203 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 4/202 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.98% 2/204 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	1.00% 2/201 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	3.4% 7/203 • Number of events 7 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Respiratory, thoracic and mediastinal disorders Asthma	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/201 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Gastrointestinal disorders Diarrhoea	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 4/204 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/201 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/203 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/203 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.5% 5/200 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Gastrointestinal disorders Nausea	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/201 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 1/50 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/203 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/202 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Musculoskeletal and connective tissue disorders Myalgia	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/201 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	1.5% 3/203 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	1.0% 2/200 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 4/202 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	1.00% 2/201 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	1.5% 3/200 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/202 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/202 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Musculoskeletal and connective tissue disorders Muscle spasms	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
General disorders Pyrexia	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.98% 2/204 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.5% 5/201 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/203 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	1.0% 2/200 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/202 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
General disorders Malaise	2.0% 1/49 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/50 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 4/202 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 1/50 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Ear and labyrinth disorders Ear pain	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/204 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 1/50 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.98% 2/204 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	1.5% 3/203 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 1/50 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/203 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.99% 2/202 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Gastrointestinal disorders Toothache	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 1/50 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.49% 1/203 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/200 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.50% 1/201 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 1/50 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	— 0/0 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.
Reproductive system and breast disorders Pelvic prolapse	0.00% 0/49 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/204 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/201 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	2.0% 1/50 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/203 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/200 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.	0.00% 0/202 • For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination.

Additional Information

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Seqirus

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Results disclosure agreements

• Principal investigator is a sponsor employee CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
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