Trial Outcomes & Findings for Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects (NCT NCT00434577)

NCT ID: NCT00434577

Last Updated: 2019-03-15

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

715 participants

Primary outcome timeframe

One month after the second vaccination (Month 3)

Results posted on

2019-03-15

Participant Flow

Out of 715 subjects enrolled, only 714 were vaccinated.

Participant milestones

Participant milestones
Measure	GSK1437173A _LD Group Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Months 0-3 STARTED	164	166	165	165	54
Months 0-3 COMPLETED	161	164	161	164	51
Months 0-3 NOT COMPLETED	3	2	4	1	3
Month 12 STARTED	156	159	159	161	50
Month 12 COMPLETED	156	159	159	161	50
Month 12 NOT COMPLETED	0	0	0	0	0
Month 24 STARTED	150	155	154	157	49
Month 24 COMPLETED	150	155	154	157	49
Month 24 NOT COMPLETED	0	0	0	0	0
Month 36 STARTED	147	147	150	155	47
Month 36 COMPLETED	147	147	150	155	47
Month 36 NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1437173A _LD Group Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Months 0-3 Serious Adverse Event	0	0	1	0	0
Months 0-3 Adverse Event	0	1	1	0	0
Months 0-3 Lost to Follow-up	0	0	0	0	2
Months 0-3 Protocol Violation	1	0	1	0	0
Months 0-3 Withdrawal by Subject	2	1	1	1	1

Baseline Characteristics

Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1437173A _LD Group n=164 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=166 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED GROUP n=54 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Total n=714 Participants Total of all reporting groups
Age, Continuous	72.8 Years STANDARD_DEVIATION 5.5 • n=5 Participants	72.9 Years STANDARD_DEVIATION 5.1 • n=7 Participants	73.0 Years STANDARD_DEVIATION 5.7 • n=5 Participants	73.1 Years STANDARD_DEVIATION 5.9 • n=4 Participants	72.1 Years STANDARD_DEVIATION 5.2 • n=21 Participants	72.9 Years STANDARD_DEVIATION 5.5 • n=8 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	100 Participants n=7 Participants	85 Participants n=5 Participants	95 Participants n=4 Participants	36 Participants n=21 Participants	404 Participants n=8 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	66 Participants n=7 Participants	80 Participants n=5 Participants	70 Participants n=4 Participants	18 Participants n=21 Participants	310 Participants n=8 Participants
Race/Ethnicity, Customized Geographic ancestry · African Heritage/African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Central/South Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Arabic/North African Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian/European Heritage	162 Participants n=5 Participants	163 Participants n=7 Participants	164 Participants n=5 Participants	165 Participants n=4 Participants	54 Participants n=21 Participants	708 Participants n=8 Participants
Race/Ethnicity, Customized Geographic ancestry · Other	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: One month after the second vaccination (Month 3)

Population: The analysis was performed on the According-to-Protocol(ATP) cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=119 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=120 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=117 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=118 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=36 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers	1801.23 T-cells/million cells Interval 907.17 to 2930.71	1722.83 T-cells/million cells Interval 1172.96 to 3229.73	1778.48 T-cells/million cells Interval 1154.88 to 3407.91	491.03 T-cells/million cells Interval 320.65 to 768.17	388.49 T-cells/million cells Interval 208.57 to 610.66

PRIMARY outcome

Timeframe: One month after the second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old. The odds-ratios are calculated using the the frequency of CD4 secreting cytokines, upon in vitro stimulation with the specific antigen, at the numerator and the frequency of the CD4 secreting cytokines with the medium only (background level) at the denominator. The odds-ratios represent the fold-change in the specific response compared to the background level.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=119 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=120 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=117 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=118 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=36 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers	12.83 Fold Change Standard Deviation 13.13	15.00 Fold Change Standard Deviation 15.86	21.53 Fold Change Standard Deviation 71.96	5.92 Fold Change Standard Deviation 9.56	4.05 Fold Change Standard Deviation 3.20

PRIMARY outcome

Timeframe: One month after the second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=119 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=120 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=117 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=118 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=36 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers	2269.84 T-cells/million cells Standard Deviation 1934.55	2441.95 T-cells/million cells Standard Deviation 2055.11	2449.90 T-cells/million cells Standard Deviation 1808.00	681.73 T-cells/million cells Standard Deviation 665.17	512.55 T-cells/million cells Standard Deviation 463.35

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=152 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=144 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=48 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers CD4-All Doubles, Day 0	194.47 T-cells/million cells Standard Deviation 214.96	225.47 T-cells/million cells Standard Deviation 370.67	201.17 T-cells/million cells Standard Deviation 230.96	203.70 T-cells/million cells Standard Deviation 221.97	145.95 T-cells/million cells Standard Deviation 164.57
Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers CD4-All Doubles, Month 2	459.01 T-cells/million cells Standard Deviation 401.25	482.84 T-cells/million cells Standard Deviation 425.73	489.45 T-cells/million cells Standard Deviation 423.52	173.91 T-cells/million cells Standard Deviation 181.86	230.28 T-cells/million cells Standard Deviation 250.70
Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers CD4-All Double, Month 3	2246.29 T-cells/million cells Standard Deviation 1976.42	2372.07 T-cells/million cells Standard Deviation 1877.43	2569.29 T-cells/million cells Standard Deviation 2052.74	670.80 T-cells/million cells Standard Deviation 606.93	550.11 T-cells/million cells Standard Deviation 448.15

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=144 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=148 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=48 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker Day 0	156.54 T-cells/million cells Standard Deviation 199.12	169.01 T-cells/million cells Standard Deviation 326.34	152.28 T-cells/million cells Standard Deviation 220.50	157.13 T-cells/million cells Standard Deviation 180.00	118.35 T-cells/million cells Standard Deviation 125.08
Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker Month 2	279.39 T-cells/million cells Standard Deviation 343.61	279.20 T-cells/million cells Standard Deviation 336.29	292.15 T-cells/million cells Standard Deviation 345.65	124.05 T-cells/million cells Standard Deviation 151.42	168.34 T-cells/million cells Standard Deviation 213.83
Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker Month 3	1179.29 T-cells/million cells Standard Deviation 1021.14	1296.04 T-cells/million cells Standard Deviation 1132.18	1417.40 T-cells/million cells Standard Deviation 1303.60	363.23 T-cells/million cells Standard Deviation 364.74	341.36 T-cells/million cells Standard Deviation 313.79

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=152 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=144 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=48 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker Day 0	171.21 T-cells/million cells Standard Deviation 208.49	191.28 T-cells/million cells Standard Deviation 307.40	180.85 T-cells/million cells Standard Deviation 193.48	172.41 T-cells/million cells Standard Deviation 184.32	125.22 T-cells/million cells Standard Deviation 134.81
Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker Month 2	416.12 T-cells/million cells Standard Deviation 369.85	442.17 T-cells/million cells Standard Deviation 363.10	438.27 T-cells/million cells Standard Deviation 378.81	150.47 T-cells/million cells Standard Deviation 160.29	199.34 T-cells/million cells Standard Deviation 224.39
Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker Month 3	2077.06 T-cells/million cells Standard Deviation 1860.40	2156.40 T-cells/million cells Standard Deviation 1697.78	2315.84 T-cells/million cells Standard Deviation 1847.24	597.76 T-cells/million cells Standard Deviation 531.07	491.06 T-cells/million cells Standard Deviation 396.39

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=152 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=144 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=48 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker Day 0	97.28 T-cells//million cells Standard Deviation 137.06	121.05 T-cells//million cells Standard Deviation 296.79	116.91 T-cells//million cells Standard Deviation 173.65	110.66 T-cells//million cells Standard Deviation 162.02	81.40 T-cells//million cells Standard Deviation 107.44
Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker Month 2	251.94 T-cells//million cells Standard Deviation 277.71	256.15 T-cells//million cells Standard Deviation 304.91	263.39 T-cells//million cells Standard Deviation 284.96	95.84 T-cells//million cells Standard Deviation 125.15	120.73 T-cells//million cells Standard Deviation 148.24
Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker Month 3	1317.39 T-cells//million cells Standard Deviation 1304.53	1282.96 T-cells//million cells Standard Deviation 1183.69	1389.62 T-cells//million cells Standard Deviation 1231.76	350.23 T-cells//million cells Standard Deviation 380.60	252.86 T-cells//million cells Standard Deviation 253.55

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=152 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=144 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=149 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=48 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker Day 0	142.88 T-cells/million cells Standard Deviation 169.52	153.80 T-cells/million cells Standard Deviation 214.95	151.37 T-cells/million cells Standard Deviation 160.38	155.90 T-cells/million cells Standard Deviation 187.47	111.55 T-cells/million cells Standard Deviation 126.92
Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker Month 2	385.34 T-cells/million cells Standard Deviation 348.25	405.95 T-cells/million cells Standard Deviation 359.46	417.20 T-cells/million cells Standard Deviation 361.59	132.62 T-cells/million cells Standard Deviation 144.06	182.82 T-cells/million cells Standard Deviation 195.36
Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker Month 3	2014.37 T-cells/million cells Standard Deviation 1849.25	2154.81 T-cells/million cells Standard Deviation 1799.64	2303.13 T-cells/million cells Standard Deviation 1987.94	567.33 T-cells/million cells Standard Deviation 566.48	433.56 T-cells/million cells Standard Deviation 391.64

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=126 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=120 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=118 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=119 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=39 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers CD8-All Doubles, Day 0	74.62 T-cells/million cells Standard Deviation 118.02	98.88 T-cells/million cells Standard Deviation 164.52	122.37 T-cells/million cells Standard Deviation 221.20	80.54 T-cells/million cells Standard Deviation 121.84	108.21 T-cells/million cells Standard Deviation 330.11
Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers CD8-All Doubles, Month 2	85.29 T-cells/million cells Standard Deviation 139.32	106.23 T-cells/million cells Standard Deviation 141.63	86.35 T-cells/million cells Standard Deviation 168.10	120.06 T-cells/million cells Standard Deviation 221.20	98.97 T-cells/million cells Standard Deviation 299.34
Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers CD8-All Doubles, Month 3	96.43 T-cells/million cells Standard Deviation 155.37	88.77 T-cells/million cells Standard Deviation 140.95	117.70 T-cells/million cells Standard Deviation 196.09	112.99 T-cells/million cells Standard Deviation 165.52	116.41 T-cells/million cells Standard Deviation 450.85

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=98 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=91 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=98 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=95 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=32 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker Day 0	60.35 T-cells/million cells Standard Deviation 97.12	75.79 T-cells/million cells Standard Deviation 114.55	106.39 T-cells/million cells Standard Deviation 199.96	70.69 T-cells/million cells Standard Deviation 121.23	123.99 T-cells/million cells Standard Deviation 360.75
Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker Month 2	65.97 T-cells/million cells Standard Deviation 111.02	106.74 T-cells/million cells Standard Deviation 133.15	72.58 T-cells/million cells Standard Deviation 92.99	106.02 T-cells/million cells Standard Deviation 184.40	95.05 T-cells/million cells Standard Deviation 326.45
Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker Month 3	88.62 T-cells/million cells Standard Deviation 136.13	76.92 T-cells/million cells Standard Deviation 123.74	95.01 T-cells/million cells Standard Deviation 138.77	96.91 T-cells/million cells Standard Deviation 161.10	125.69 T-cells/million cells Standard Deviation 480.05

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=97 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=91 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=88 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=90 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=27 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker Day 0	81.42 T-cells/million cells Standard Deviation 108.62	83.13 T-cells/million cells Standard Deviation 131.07	90.71 T-cells/million cells Standard Deviation 140.18	63.56 T-cells/million cells Standard Deviation 89.18	43.03 T-cells/million cells Standard Deviation 58.88
Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker Month 2	61.05 T-cells/million cells Standard Deviation 106.36	78.18 T-cells/million cells Standard Deviation 92.65	83.07 T-cells/million cells Standard Deviation 186.88	82.47 T-cells/million cells Standard Deviation 126.08	68.98 T-cells/million cells Standard Deviation 85.29
Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker Month 3	69.06 T-cells/million cells Standard Deviation 97.12	65.08 T-cells/million cells Standard Deviation 83.71	103.17 T-cells/million cells Standard Deviation 179.57	82.95 T-cells/million cells Standard Deviation 99.47	56.42 T-cells/million cells Standard Deviation 120.85

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=100 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=102 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=108 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=97 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=33 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker Day 0	74.94 T-cells/million cells Standard Deviation 113.07	87.33 T-cells/million cells Standard Deviation 117.28	111.54 T-cells/million cells Standard Deviation 204.36	81.54 T-cells/million cells Standard Deviation 119.17	122.68 T-cells/million cells Standard Deviation 362.64
Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker Month 2	71.42 T-cells/million cells Standard Deviation 96.41	83.01 T-cells/million cells Standard Deviation 124.50	75.88 T-cells/million cells Standard Deviation 129.33	111.15 T-cells/million cells Standard Deviation 217.08	115.82 T-cells/million cells Standard Deviation 356.29
Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker Month 3	86.81 T-cells/million cells Standard Deviation 120.39	76.75 T-cells/million cells Standard Deviation 137.37	99.07 T-cells/million cells Standard Deviation 139.42	106.97 T-cells/million cells Standard Deviation 167.59	136.22 T-cells/million cells Standard Deviation 470.58

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=78 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=70 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=77 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=76 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=25 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker Day 0	41.35 T-cells/million cells Standard Deviation 54.48	61.30 T-cells/million cells Standard Deviation 118.43	56.85 T-cells/million cells Standard Deviation 78.31	35.96 T-cells/million cells Standard Deviation 69.51	59.94 T-cells/million cells Standard Deviation 75.13
Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker Month 2	63.87 T-cells/million cells Standard Deviation 82.02	66.76 T-cells/million cells Standard Deviation 90.29	47.20 T-cells/million cells Standard Deviation 64.54	71.20 T-cells/million cells Standard Deviation 93.18	54.63 T-cells/million cells Standard Deviation 69.92
Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker Month 3	69.50 T-cells/million cells Standard Deviation 105.36	65.34 T-cells/million cells Standard Deviation 64.17	85.57 T-cells/million cells Standard Deviation 105.34	76.19 T-cells/million cells Standard Deviation 72.44	33.12 T-cells/million cells Standard Deviation 47.32

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=157 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=156 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=153 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=50 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Anti-gE Specific Antibody Concentrations Anti-gE, Day 0	351.6 EL.U/mL Interval 306.2 to 403.8	312.8 EL.U/mL Interval 268.1 to 365.0	416.1 EL.U/mL Interval 355.0 to 487.7	337.2 EL.U/mL Interval 285.8 to 397.7	323.7 EL.U/mL Interval 245.2 to 427.3
Anti-gE Specific Antibody Concentrations Anti-gE, Month 2	3667.6 EL.U/mL Interval 3158.6 to 4258.7	4139.4 EL.U/mL Interval 3443.8 to 4975.4	5485.6 EL.U/mL Interval 4657.2 to 6461.3	361.5 EL.U/mL Interval 304.6 to 429.0	2148.9 EL.U/mL Interval 1461.8 to 3158.9
Anti-gE Specific Antibody Concentrations Anti-gE, Month 3	9315.3 EL.U/mL Interval 8283.2 to 10476.1	12898.0 EL.U/mL Interval 11681.2 to 14241.6	15626.5 EL.U/mL Interval 14030.3 to 17404.3	6287.2 EL.U/mL Interval 5372.0 to 7358.3	4298.3 EL.U/mL Interval 3220.0 to 5737.7

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), as assessed by ELISA.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=157 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=156 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=153 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=50 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations Anti-VZV, Day 0	1334.9 mIU/mL Interval 1181.9 to 1507.7	1212.0 mIU/mL Interval 1063.9 to 1380.7	1510.7 mIU/mL Interval 1336.4 to 1707.7	1356.3 mIU/mL Interval 1184.9 to 1552.6	1422.5 mIU/mL Interval 1153.4 to 1754.5
Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations Anti-VZV, Month 2	4408.1 mIU/mL Interval 3847.7 to 5050.1	5131.9 mIU/mL Interval 4469.8 to 5892.0	6511.7 mIU/mL Interval 5723.1 to 7409.0	1341.6 mIU/mL Interval 1177.7 to 1528.3	3481.2 mIU/mL Interval 2756.0 to 4397.3
Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations Anti-VZV, Month 3	8821.6 mIU/mL Interval 7959.3 to 9777.4	11451.0 mIU/mL Interval 10507.9 to 12478.7	14143.5 mIU/mL Interval 12876.9 to 15534.7	6432.2 mIU/mL Interval 5591.8 to 7398.9	5357.6 mIU/mL Interval 4297.3 to 6679.4

SECONDARY outcome

Timeframe: At Months 12, 24 and 36

Population: The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.

Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=148 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=45 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers CD4-All Doubles, Month 12	1135.8 T-cells/million cells Standard Deviation 936.0	1275.5 T-cells/million cells Standard Deviation 1195.4	1274.0 T-cells/million cells Standard Deviation 995.0	340.4 T-cells/million cells Standard Deviation 296.8	274.5 T-cells/million cells Standard Deviation 217.3
Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers CD4-All Doubles, Month 24	1004.1 T-cells/million cells Standard Deviation 838.8	1195.5 T-cells/million cells Standard Deviation 1375.5	1079.9 T-cells/million cells Standard Deviation 948.0	244.1 T-cells/million cells Standard Deviation 233.2	285.2 T-cells/million cells Standard Deviation 255.6
Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers CD4-All Doubles, Month 36	827.3 T-cells/million cells Standard Deviation 922.9	969.7 T-cells/million cells Standard Deviation 1034.9	896.3 T-cells/million cells Standard Deviation 770.4	239.7 T-cells/million cells Standard Deviation 181.7	229.7 T-cells/million cells Standard Deviation 217.1

SECONDARY outcome

Timeframe: At Months 12, 24 and 36

Among other activation markers expressed were interleukin-2 \[IL-2\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=148 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=45 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker Month 12	659.9 T-cells/million cells Standard Deviation 594.3	767.8 T-cells/million cells Standard Deviation 895.1	718.9 T-cells/million cells Standard Deviation 634.2	235.5 T-cells/million cells Standard Deviation 244.7	176.8 T-cells/million cells Standard Deviation 152.7
Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker Month 24	541.9 T-cells/million cells Standard Deviation 503.1	668.9 T-cells/million cells Standard Deviation 1140.6	543.6 T-cells/million cells Standard Deviation 554.7	157.0 T-cells/million cells Standard Deviation 183.4	181.2 T-cells/million cells Standard Deviation 158.4
Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker Month 36	491.8 T-cells/million cells Standard Deviation 604.1	583.3 T-cells/million cells Standard Deviation 819.0	492.3 T-cells/million cells Standard Deviation 437.0	172.2 T-cells/million cells Standard Deviation 155.1	162.0 T-cells/million cells Standard Deviation 151.4

SECONDARY outcome

Timeframe: At Months 12, 24 and 36

Among other activation markers expressed were interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=148 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=45 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker Month 12	1056.2 T-cells/million cells Standard Deviation 901.0	1164.7 T-cells/million cells Standard Deviation 1029.1	1168.3 T-cells/million cells Standard Deviation 935.4	291.7 T-cells/million cells Standard Deviation 266.6	243.9 T-cells/million cells Standard Deviation 204.8
Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker Month 24	943.0 T-cells/million cells Standard Deviation 809.5	1100.2 T-cells/million cells Standard Deviation 1158.9	1007.8 T-cells/million cells Standard Deviation 909.5	213.0 T-cells/million cells Standard Deviation 207.4	233.0 T-cells/million cells Standard Deviation 244.5
Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker Month 36	768.9 T-cells/million cells Standard Deviation 871.5	890.2 T-cells/million cells Standard Deviation 883.3	834.7 T-cells/million cells Standard Deviation 743.9	205.8 T-cells/million cells Standard Deviation 154.5	213.9 T-cells/million cells Standard Deviation 202.2

SECONDARY outcome

Timeframe: At Month 12, 24 and 36

Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=148 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=45 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker Month 12	673.7 T-cells/million cells Standard Deviation 616.0	736.2 T-cells/million cells Standard Deviation 878.5	736.7 T-cells/million cells Standard Deviation 660.7	193.2 T-cells/million cells Standard Deviation 239.4	136.0 T-cells/million cells Standard Deviation 132.8
Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker Month 24	567.9 T-cells/million cells Standard Deviation 527.7	663.1 T-cells/million cells Standard Deviation 1097.0	591.5 T-cells/million cells Standard Deviation 586.6	144.1 T-cells/million cells Standard Deviation 196.1	133.0 T-cells/million cells Standard Deviation 158.1
Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker Month 36	497.4 T-cells/million cells Standard Deviation 652.5	567.9 T-cells/million cells Standard Deviation 808.4	510.7 T-cells/million cells Standard Deviation 522.1	117.9 T-cells/million cells Standard Deviation 151.7	98.1 T-cells/million cells Standard Deviation 116.0

SECONDARY outcome

Timeframe: At Month 12, 24 and 36

Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=150 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=148 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=151 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=45 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker Month 12	969.0 T-cells/million cells Standard Deviation 811.8	1057.2 T-cells/million cells Standard Deviation 943.4	1062.8 T-cells/million cells Standard Deviation 850.3	267.5 T-cells/million cells Standard Deviation 246.0	221.0 T-cells/million cells Standard Deviation 180.9
Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker Month 24	935.2 T-cells/million cells Standard Deviation 801.5	1079.9 T-cells/million cells Standard Deviation 1040.1	981.6 T-cells/million cells Standard Deviation 890.9	210.8 T-cells/million cells Standard Deviation 187.2	270.3 T-cells/million cells Standard Deviation 248.6
Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker Month 36	753.0 T-cells/million cells Standard Deviation 852.9	912.9 T-cells/million cells Standard Deviation 1009.2	823.0 T-cells/million cells Standard Deviation 727.9	202.5 T-cells/million cells Standard Deviation 166.3	202.8 T-cells/million cells Standard Deviation 187.1

SECONDARY outcome

Timeframe: At Months 12, 24 and 36

Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=156 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=159 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=159 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=160 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=50 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Anti-gE Specific Antibody Concentrations Anti-gE, Month 12	3384.8 EL.U/mL Interval 2987.2 to 3835.4	4280.3 EL.U/mL Interval 3818.4 to 4798.0	5258.2 EL.U/mL Interval 4725.2 to 5851.3	1664.5 EL.U/mL Interval 1443.7 to 1919.1	1888.2 EL.U/mL Interval 1452.7 to 2454.1
Anti-gE Specific Antibody Concentrations Anti-gE, Month 24	2363.8 EL.U/mL Interval 2081.0 to 2685.0	2784.6 EL.U/mL Interval 2494.0 to 3109.1	3390.0 EL.U/mL Interval 3013.6 to 3813.5	1126.3 EL.U/mL Interval 982.2 to 1291.6	1339.1 EL.U/mL Interval 1038.3 to 1727.0
Anti-gE Specific Antibody Concentrations Anti-gE, Month 36	2064.1 EL.U/mL Interval 1834.6 to 2322.3	2444.3 EL.U/mL Interval 2175.2 to 2746.8	2956.4 EL.U/mL Interval 2653.6 to 3293.7	959.5 EL.U/mL Interval 831.0 to 1107.9	973.9 EL.U/mL Interval 755.4 to 1255.6

SECONDARY outcome

Timeframe: At Months 12, 24 and 36

Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=149 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=155 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=154 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=157 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=48 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations Anti-VZV, Month 12	4190.1 mIU/mL Interval 3845.4 to 4565.8	4761.3 mIU/mL Interval 4367.0 to 5191.3	5559.1 mIU/mL Interval 5141.5 to 6010.7	2704.1 mIU/mL Interval 2424.5 to 3016.0	2733.8 mIU/mL Interval 2208.8 to 3383.7
Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations Anti-VZV, Month 24	2557.4 mIU/mL Interval 2397.5 to 2727.8	2673.6 mIU/mL Interval 2523.8 to 2832.3	2976.0 mIU/mL Interval 2819.5 to 3141.3	1849.3 mIU/mL Interval 1701.8 to 2009.5	1922.6 mIU/mL Interval 1643.1 to 2249.6
Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations Anti-VZV, Month 36	2426.6 mIU/mL Interval 2257.2 to 2608.8	2555.0 mIU/mL Interval 2385.8 to 2736.3	2826.7 mIU/mL Interval 2648.4 to 3017.0	1729.9 mIU/mL Interval 1582.5 to 1891.1	1739.9 mIU/mL Interval 1481.0 to 2044.0

SECONDARY outcome

Timeframe: At pre-vaccination (Day 0) and at Month 3

Population: The analysis was performed on the Total cohort for persistence at Month 12, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Month 12.

Memory B cells specific to the gE antigen, as assessed by the enzyme-linked immunosorbent spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Results were tabulated for subjects aged 70 years and older.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=19 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=23 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=23 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=21 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=8 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Frequency of VZV-specific Memory B-cells in a Subset of Subjects Memory B-cells, Day 0	336.5 B-cells/million cells Standard Deviation 359.5	490.4 B-cells/million cells Standard Deviation 704.7	356.6 B-cells/million cells Standard Deviation 348.0	332.3 B-cells/million cells Standard Deviation 404.9	380.6 B-cells/million cells Standard Deviation 299.7
Frequency of VZV-specific Memory B-cells in a Subset of Subjects Memory B-cells, Month 3	5699.3 B-cells/million cells Standard Deviation 8166.2	5997.1 B-cells/million cells Standard Deviation 5034.6	9707.5 B-cells/million cells Standard Deviation 8787.1	1583.7 B-cells/million cells Standard Deviation 2266.0	1042.2 B-cells/million cells Standard Deviation 1139.9

SECONDARY outcome

Timeframe: At Day 0, Month 2 and Month 3

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.

Among biochemical and haematological parameters assessed were albumin \[ALB\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], calcium \[CAL\], eosinophils \[EOS\], fibrinogen \[FIB\], haematocrit \[HEM\], hemoglobin \[Hgb\], leucocytes \[LEU\], lymphocytes \[LYM\], lactate dehydrogenate \[LDH\], monocytes \[MON\], neutrophils \[NEU\], partial thromboplastin time \[PTPT\], platelets \[PLA\], pro thrombin time \[PTT\], red blood cells \[RBC\], serum creatinine \[SCREA\], total protein \[TP\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=164 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=166 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=164 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=54 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Number of Subjects With Different Biochemical and Haematological Levels BAS, Month 2 · Below	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels BAS, Month 2 · Within	153 Participants	155 Participants	152 Participants	154 Participants	47 Participants
Number of Subjects With Different Biochemical and Haematological Levels BAS, Month 3 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels BAS, Month 3 · Below	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels BAS, Month 3 · Above	10 Participants	13 Participants	12 Participants	9 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels CAL, Month 2 · Within	68 Participants	75 Participants	68 Participants	71 Participants	22 Participants
Number of Subjects With Different Biochemical and Haematological Levels CAL, Month 3 · Above	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels EOS, Day 0 · Unknown	8 Participants	11 Participants	5 Participants	6 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels EOS, Day 0 · Below	13 Participants	11 Participants	12 Participants	10 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels EOS, Day 0 · Above	13 Participants	17 Participants	12 Participants	12 Participants	4 Participants
Number of Subjects With Different Biochemical and Haematological Levels EOS, Month 2 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels FIB, Day 0 · Within	36 Participants	34 Participants	36 Participants	39 Participants	10 Participants
Number of Subjects With Different Biochemical and Haematological Levels FIB, Month 2 · Within	40 Participants	35 Participants	37 Participants	35 Participants	12 Participants
Number of Subjects With Different Biochemical and Haematological Levels FIB, Month 2 · Above	32 Participants	41 Participants	35 Participants	38 Participants	10 Participants
Number of Subjects With Different Biochemical and Haematological Levels FIB, Month 3 · Unknown	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels HEM, Day 0 · Above	1 Participants	3 Participants	8 Participants	8 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels HEM, Month 2 · Below	27 Participants	19 Participants	25 Participants	28 Participants	4 Participants
Number of Subjects With Different Biochemical and Haematological Levels HEM, Month 3 · Unknown	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels HgB, Month 2 · Below	26 Participants	22 Participants	26 Participants	26 Participants	6 Participants
Number of Subjects With Different Biochemical and Haematological Levels HgB, Month 2 · Within	134 Participants	140 Participants	134 Participants	134 Participants	45 Participants
Number of Subjects With Different Biochemical and Haematological Levels HgB, Month 3 · Unknown	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LEU, Day 0 · Below	3 Participants	5 Participants	2 Participants	6 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels LEU, Day 0 · Within	153 Participants	147 Participants	153 Participants	153 Participants	52 Participants
Number of Subjects With Different Biochemical and Haematological Levels LEU, Month 2 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LEU, Month 2 · Above	7 Participants	9 Participants	5 Participants	11 Participants	5 Participants
Number of Subjects With Different Biochemical and Haematological Levels LEU, Month 3 · Within	150 Participants	150 Participants	149 Participants	150 Participants	50 Participants
Number of Subjects With Different Biochemical and Haematological Levels LEU, Month 3 · Above	8 Participants	6 Participants	7 Participants	8 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels LYM, Month 2 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LYM, Month 2 · Within	144 Participants	144 Participants	131 Participants	147 Participants	42 Participants
Number of Subjects With Different Biochemical and Haematological Levels LYM, Month 3 · Below	12 Participants	8 Participants	19 Participants	20 Participants	7 Participants
Number of Subjects With Different Biochemical and Haematological Levels LYM, Month 3 · Above	4 Participants	2 Participants	4 Participants	2 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTPT, Day 0 · Within	42 Participants	42 Participants	42 Participants	43 Participants	11 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTPT, Day 0 · Above	3 Participants	7 Participants	6 Participants	5 Participants	5 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTPT, Month 2 · Within	59 Participants	58 Participants	57 Participants	64 Participants	20 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTPT, Month 2 · Above	6 Participants	11 Participants	6 Participants	6 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTPT, Month 3 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTPT, Month 3 · Below	4 Participants	4 Participants	6 Participants	5 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTPT, Month 3 · Within	62 Participants	61 Participants	59 Participants	62 Participants	18 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTPT, Month 3 · Above	4 Participants	12 Participants	7 Participants	8 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels PLA, Day 0 · Unknown	1 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PLA, Day 0 · Below	6 Participants	4 Participants	9 Participants	10 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels PLA, Day 0 · Within	147 Participants	150 Participants	149 Participants	148 Participants	49 Participants
Number of Subjects With Different Biochemical and Haematological Levels PLA, Day 0 · Above	10 Participants	8 Participants	6 Participants	7 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels PLA, Month 3 · Above	5 Participants	5 Participants	5 Participants	3 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTT, Month 2 · Above	2 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTT, Month 3 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTT, Month 3 · Within	62 Participants	64 Participants	63 Participants	64 Participants	19 Participants
Number of Subjects With Different Biochemical and Haematological Levels RBC, Day 0 · Above	3 Participants	5 Participants	9 Participants	5 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels RBC, Month 2 · Below	25 Participants	23 Participants	27 Participants	24 Participants	8 Participants
Number of Subjects With Different Biochemical and Haematological Levels RBC, Month 3 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels RBC, Month 3 · Within	129 Participants	138 Participants	131 Participants	136 Participants	46 Participants
Number of Subjects With Different Biochemical and Haematological Levels RBC, Month 3 · Above	3 Participants	3 Participants	4 Participants	4 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels TP, Month 3 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALT, Day 0 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALT, Day 0 · Below	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALT, Month 3 · Above	7 Participants	12 Participants	6 Participants	13 Participants	5 Participants
Number of Subjects With Different Biochemical and Haematological Levels AST, Day 0 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALB, Day 0 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALB, Day 0 · Below	13 Participants	12 Participants	14 Participants	12 Participants	4 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALB, Day 0 · Within	57 Participants	64 Participants	59 Participants	61 Participants	19 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALB, Day 0 · Above	4 Participants	1 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALB, Month 2 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALB, Month 2 · Below	13 Participants	14 Participants	11 Participants	17 Participants	6 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALB, Month 2 · Within	57 Participants	61 Participants	62 Participants	55 Participants	16 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALB, Month 2 · Above	2 Participants	2 Participants	1 Participants	3 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALB, Month 3 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALB, Month 3 · Within	61 Participants	62 Participants	61 Participants	55 Participants	17 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALB, Month 3 · Above	1 Participants	3 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALB, Month 3 · Below	8 Participants	12 Participants	9 Participants	17 Participants	4 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALT, Day 0 · Within	150 Participants	151 Participants	152 Participants	154 Participants	50 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALT, Day 0 · Above	13 Participants	13 Participants	12 Participants	10 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALT, Month 2 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALT, Month 2 · Below	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALT, Month 2 · Within	152 Participants	149 Participants	155 Participants	150 Participants	48 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALT, Month 2 · Above	9 Participants	14 Participants	7 Participants	13 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALT, Month 3 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALT, Month 3 · Below	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels AST, Day 0 · Below	0 Participants	1 Participants	1 Participants	3 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels AST, Day 0 · Within	156 Participants	154 Participants	156 Participants	148 Participants	51 Participants
Number of Subjects With Different Biochemical and Haematological Levels ALT, Month 3 · Within	152 Participants	150 Participants	154 Participants	150 Participants	46 Participants
Number of Subjects With Different Biochemical and Haematological Levels AST, Day 0 · Above	8 Participants	11 Participants	7 Participants	14 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels AST, Month 2 · Within	150 Participants	151 Participants	151 Participants	151 Participants	51 Participants
Number of Subjects With Different Biochemical and Haematological Levels AST, Month 2 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels RBC, Day 0 · Within	137 Participants	135 Participants	128 Participants	136 Participants	42 Participants
Number of Subjects With Different Biochemical and Haematological Levels AST, Month 2 · Below	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels CAL, Day 0 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels AST, Month 2 · Above	12 Participants	12 Participants	11 Participants	13 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels AST, Month 3 · Unknown	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels AST, Month 3 · Below	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels AST, Month 3 · Within	151 Participants	146 Participants	153 Participants	153 Participants	48 Participants
Number of Subjects With Different Biochemical and Haematological Levels AST, Month 3 · Above	9 Participants	15 Participants	6 Participants	11 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels BAS, Day 0 · Unknown	7 Participants	11 Participants	5 Participants	6 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels BAS, Day 0 · Below	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels BAS, Day 0 · Within	148 Participants	147 Participants	153 Participants	153 Participants	50 Participants
Number of Subjects With Different Biochemical and Haematological Levels BAS, Day 0 · Above	9 Participants	7 Participants	6 Participants	6 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels BAS, Month 2 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels BAS, Month 2 · Above	9 Participants	8 Participants	8 Participants	9 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels BAS, Month 3 · Within	150 Participants	151 Participants	147 Participants	155 Participants	48 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTT, Month 3 · Below	5 Participants	10 Participants	6 Participants	8 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels PLA, Month 2 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTT, Month 3 · Above	3 Participants	3 Participants	3 Participants	3 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels RBC, Day 0 · Unknown	1 Participants	5 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels RBC, Day 0 · Below	23 Participants	21 Participants	25 Participants	23 Participants	9 Participants
Number of Subjects With Different Biochemical and Haematological Levels RBC, Month 2 · Unknown	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels RBC, Month 2 · Within	136 Participants	138 Participants	128 Participants	135 Participants	42 Participants
Number of Subjects With Different Biochemical and Haematological Levels RBC, Month 2 · Above	1 Participants	2 Participants	6 Participants	5 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels RBC, Month 3 · Below	27 Participants	23 Participants	26 Participants	23 Participants	5 Participants
Number of Subjects With Different Biochemical and Haematological Levels SCREA, Day 0 · Unknown	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels SCREA, Day 0 · Below	4 Participants	2 Participants	3 Participants	3 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels SCREA, Day 0 · Within	130 Participants	132 Participants	128 Participants	135 Participants	43 Participants
Number of Subjects With Different Biochemical and Haematological Levels SCREA, Day 0 · Above	29 Participants	31 Participants	32 Participants	27 Participants	11 Participants
Number of Subjects With Different Biochemical and Haematological Levels SCREA, Month 2 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels SCREA, Month 2 · Below	3 Participants	2 Participants	1 Participants	3 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels SCREA, Month 2 · Within	135 Participants	131 Participants	129 Participants	131 Participants	38 Participants
Number of Subjects With Different Biochemical and Haematological Levels SCREA, Month 2 · Above	24 Participants	31 Participants	32 Participants	30 Participants	11 Participants
Number of Subjects With Different Biochemical and Haematological Levels SCREA, Month 3 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels SCREA, Month 3 · Below	3 Participants	3 Participants	2 Participants	2 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PLA, Month 2 · Below	6 Participants	7 Participants	11 Participants	12 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels PLA, Month 2 · Within	150 Participants	152 Participants	145 Participants	145 Participants	49 Participants
Number of Subjects With Different Biochemical and Haematological Levels SCREA, Month 3 · Within	132 Participants	127 Participants	130 Participants	134 Participants	42 Participants
Number of Subjects With Different Biochemical and Haematological Levels SCREA, Month 3 · Above	25 Participants	34 Participants	28 Participants	28 Participants	9 Participants
Number of Subjects With Different Biochemical and Haematological Levels PLA, Month 2 · Above	6 Participants	5 Participants	5 Participants	7 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels TP, Day 0 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PLA, Month 3 · Unknown	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels TP, Day 0 · Below	6 Participants	2 Participants	9 Participants	3 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels TP, Day 0 · Within	68 Participants	75 Participants	66 Participants	72 Participants	23 Participants
Number of Subjects With Different Biochemical and Haematological Levels TP, Day 0 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels TP, Month 2 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels TP, Month 2 · Below	6 Participants	2 Participants	9 Participants	4 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels TP, Month 2 · Within	66 Participants	75 Participants	65 Participants	71 Participants	20 Participants
Number of Subjects With Different Biochemical and Haematological Levels TP, Month 2 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PLA, Month 3 · Below	6 Participants	6 Participants	9 Participants	12 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels TP, Month 3 · Below	3 Participants	7 Participants	13 Participants	6 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels TP, Month 3 · Within	67 Participants	70 Participants	58 Participants	69 Participants	21 Participants
Number of Subjects With Different Biochemical and Haematological Levels TP, Month 3 · Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PLA, Month 3 · Within	149 Participants	153 Participants	147 Participants	148 Participants	46 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTT, Day 0 · Unknown	3 Participants	3 Participants	3 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTT, Day 0 · Below	4 Participants	9 Participants	5 Participants	5 Participants	5 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTT, Day 0 · Within	44 Participants	38 Participants	42 Participants	44 Participants	11 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTT, Day 0 · Above	2 Participants	5 Participants	3 Participants	2 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTT, Month 2 · Unknown	0 Participants	1 Participants	3 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTT, Month 2 · Below	5 Participants	10 Participants	6 Participants	7 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTT, Month 2 · Within	65 Participants	62 Participants	61 Participants	65 Participants	19 Participants
Number of Subjects With Different Biochemical and Haematological Levels CAL, Day 0 · Below	3 Participants	1 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels CAL, Day 0 · Within	70 Participants	76 Participants	72 Participants	71 Participants	23 Participants
Number of Subjects With Different Biochemical and Haematological Levels CAL, Day 0 · Above	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels CAL, Month 2 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels CAL, Month 2 · Below	4 Participants	1 Participants	5 Participants	3 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels CAL, Month 2 · Above	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels CAL, Month 3 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels CAL, Month 3 · Below	5 Participants	1 Participants	2 Participants	5 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels CAL, Month 3 · Within	64 Participants	76 Participants	70 Participants	69 Participants	21 Participants
Number of Subjects With Different Biochemical and Haematological Levels EOS, Day 0 · Within	130 Participants	127 Participants	135 Participants	137 Participants	47 Participants
Number of Subjects With Different Biochemical and Haematological Levels EOS, Month 2 · Below	11 Participants	8 Participants	15 Participants	10 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels EOS, Month 2 · Within	140 Participants	138 Participants	128 Participants	142 Participants	43 Participants
Number of Subjects With Different Biochemical and Haematological Levels EOS, Month 2 · Above	11 Participants	18 Participants	18 Participants	12 Participants	5 Participants
Number of Subjects With Different Biochemical and Haematological Levels EOS, Month 3 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels EOS, Month 3 · Below	10 Participants	9 Participants	12 Participants	8 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels EOS, Month 3 · Within	127 Participants	144 Participants	126 Participants	134 Participants	45 Participants
Number of Subjects With Different Biochemical and Haematological Levels EOS, Month 3 · Above	22 Participants	11 Participants	23 Participants	22 Participants	4 Participants
Number of Subjects With Different Biochemical and Haematological Levels FIB, Day 0 · Unknown	1 Participants	4 Participants	4 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels FIB, Day 0 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels FIB, Day 0 · Above	37 Participants	39 Participants	35 Participants	35 Participants	14 Participants
Number of Subjects With Different Biochemical and Haematological Levels FIB, Month 2 · Unknown	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels FIB, Month 2 · Below	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels FIB, Month 3 · Below	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels FIB, Month 3 · Within	40 Participants	36 Participants	40 Participants	39 Participants	9 Participants
Number of Subjects With Different Biochemical and Haematological Levels FIB, Month 3 · Above	30 Participants	40 Participants	32 Participants	35 Participants	12 Participants
Number of Subjects With Different Biochemical and Haematological Levels HEM, Day 0 · Unknown	1 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels HEM, Day 0 · Below	21 Participants	16 Participants	27 Participants	20 Participants	4 Participants
Number of Subjects With Different Biochemical and Haematological Levels HEM, Day 0 · Within	141 Participants	143 Participants	129 Participants	137 Participants	50 Participants
Number of Subjects With Different Biochemical and Haematological Levels HEM, Month 2 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels HEM, Month 2 · Within	133 Participants	144 Participants	131 Participants	132 Participants	46 Participants
Number of Subjects With Different Biochemical and Haematological Levels HEM, Month 2 · Above	2 Participants	1 Participants	5 Participants	4 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels HEM, Month 3 · Below	30 Participants	23 Participants	25 Participants	25 Participants	6 Participants
Number of Subjects With Different Biochemical and Haematological Levels HEM, Month 3 · Within	128 Participants	137 Participants	134 Participants	132 Participants	45 Participants
Number of Subjects With Different Biochemical and Haematological Levels HEM, Month 3 · Above	2 Participants	4 Participants	2 Participants	6 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels HgB, Day 0 · Unknown	1 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels HgB, Day 0 · Below	23 Participants	14 Participants	19 Participants	22 Participants	8 Participants
Number of Subjects With Different Biochemical and Haematological Levels HgB, Day 0 · Within	138 Participants	142 Participants	142 Participants	137 Participants	46 Participants
Number of Subjects With Different Biochemical and Haematological Levels HgB, Day 0 · Above	2 Participants	6 Participants	3 Participants	6 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels HgB, Month 2 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels HgB, Month 2 · Above	2 Participants	2 Participants	1 Participants	4 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels HgB, Month 3 · Below	27 Participants	21 Participants	26 Participants	24 Participants	7 Participants
Number of Subjects With Different Biochemical and Haematological Levels HgB, Month 3 · Within	131 Participants	141 Participants	133 Participants	136 Participants	44 Participants
Number of Subjects With Different Biochemical and Haematological Levels HgB, Month 3 · Above	2 Participants	2 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LEU, Day 0 · Unknown	1 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LEU, Day 0 · Above	7 Participants	10 Participants	9 Participants	6 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels LEU, Month 2 · Below	3 Participants	7 Participants	3 Participants	6 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LEU, Month 2 · Within	152 Participants	148 Participants	153 Participants	147 Participants	46 Participants
Number of Subjects With Different Biochemical and Haematological Levels LEU, Month 3 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LEU, Month 3 · Below	2 Participants	8 Participants	5 Participants	6 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LYM, Day 0 · Unknown	7 Participants	11 Participants	5 Participants	6 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels LYM, Day 0 · Below	18 Participants	13 Participants	24 Participants	17 Participants	5 Participants
Number of Subjects With Different Biochemical and Haematological Levels LYM, Day 0 · Within	137 Participants	140 Participants	130 Participants	137 Participants	44 Participants
Number of Subjects With Different Biochemical and Haematological Levels LYM, Day 0 · Above	2 Participants	2 Participants	5 Participants	5 Participants	4 Participants
Number of Subjects With Different Biochemical and Haematological Levels LYM, Month 2 · Below	15 Participants	18 Participants	23 Participants	15 Participants	7 Participants
Number of Subjects With Different Biochemical and Haematological Levels LYM, Month 2 · Above	3 Participants	2 Participants	7 Participants	2 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels LYM, Month 3 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LYM, Month 3 · Within	144 Participants	154 Participants	138 Participants	142 Participants	42 Participants
Number of Subjects With Different Biochemical and Haematological Levels LDH, Day 0 · Unknown	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LDH, Day 0 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LDH, Day 0 · Within	68 Participants	68 Participants	66 Participants	70 Participants	24 Participants
Number of Subjects With Different Biochemical and Haematological Levels LDH, Day 0 · Above	5 Participants	8 Participants	9 Participants	5 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LDH, Month 2 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LDH, Month 2 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LDH, Month 2 · Within	64 Participants	65 Participants	64 Participants	70 Participants	21 Participants
Number of Subjects With Different Biochemical and Haematological Levels LDH, Month 2 · Above	8 Participants	12 Participants	10 Participants	5 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels LDH, Month 3 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LDH, Month 3 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels LDH, Month 3 · Within	63 Participants	63 Participants	66 Participants	68 Participants	20 Participants
Number of Subjects With Different Biochemical and Haematological Levels LDH, Month 3 · Above	7 Participants	14 Participants	6 Participants	7 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels MON, Day 0 · Unknown	7 Participants	11 Participants	5 Participants	6 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels NEU, Month 3 · Below	7 Participants	3 Participants	7 Participants	6 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels MON, Day 0 · Below	1 Participants	4 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels MON, Day 0 · Within	148 Participants	142 Participants	147 Participants	148 Participants	49 Participants
Number of Subjects With Different Biochemical and Haematological Levels MON, Day 0 · Above	8 Participants	9 Participants	11 Participants	11 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels MON, Month 2 · Unknown	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels MON, Month 2 · Below	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels MON, Month 2 · Within	153 Participants	155 Participants	146 Participants	145 Participants	48 Participants
Number of Subjects With Different Biochemical and Haematological Levels MON, Month 2 · Above	9 Participants	9 Participants	13 Participants	19 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels MON, Month 3 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels MON, Month 3 · Below	2 Participants	1 Participants	1 Participants	3 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels MON, Month 3 · Within	145 Participants	151 Participants	145 Participants	148 Participants	49 Participants
Number of Subjects With Different Biochemical and Haematological Levels MON, Month 3 · Above	13 Participants	12 Participants	15 Participants	13 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels NEU, Day 0 · Unknown	8 Participants	11 Participants	5 Participants	6 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels NEU, Day 0 · Below	3 Participants	2 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels NEU, Day 0 · Within	145 Participants	141 Participants	147 Participants	146 Participants	48 Participants
Number of Subjects With Different Biochemical and Haematological Levels NEU, Day 0 · Above	8 Participants	12 Participants	9 Participants	10 Participants	2 Participants
Number of Subjects With Different Biochemical and Haematological Levels NEU, Month 2 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels NEU, Month 2 · Below	2 Participants	5 Participants	4 Participants	6 Participants	1 Participants
Number of Subjects With Different Biochemical and Haematological Levels NEU, Month 2 · Within	150 Participants	152 Participants	144 Participants	151 Participants	47 Participants
Number of Subjects With Different Biochemical and Haematological Levels NEU, Month 2 · Above	9 Participants	7 Participants	13 Participants	7 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels NEU, Month 3 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels NEU, Month 3 · Within	146 Participants	157 Participants	145 Participants	149 Participants	46 Participants
Number of Subjects With Different Biochemical and Haematological Levels NEU, Month 3 · Above	6 Participants	4 Participants	9 Participants	9 Participants	3 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTPT, Day 0 · Unknown	3 Participants	4 Participants	3 Participants	0 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTPT, Day 0 · Below	5 Participants	2 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTPT, Month 2 · Unknown	0 Participants	1 Participants	3 Participants	1 Participants	0 Participants
Number of Subjects With Different Biochemical and Haematological Levels PTPT, Month 2 · Below	7 Participants	4 Participants	6 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: At one week post-vaccination 1 (Month 0)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.

Among biochemical and haematological parameters assessed were albumin \[ALB\], calcium \[CAL\], fibrinogen \[FIB\], lactate dehydrogenase \[LDH\], partial thrombo-plastin time \[PTPT\], pro thrombin time \[PTT\], total protein \[TP\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=22 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=24 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=24 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=24 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=8 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Within · Within	12 Participants	12 Participants	12 Participants	12 Participants	4 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Within · Missing	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Above · Missing	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels LDH- Within · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels LDH- Within · Within	18 Participants	19 Participants	19 Participants	22 Participants	8 Participants
Number of German Subjects With Different Biochemical and Haematological Levels LDH- Within · Missing	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTT - Missing · Missing	22 Participants	24 Participants	22 Participants	24 Participants	8 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Below · Below	8 Participants	7 Participants	10 Participants	7 Participants	2 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Below · Within	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Below · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Below · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Within · Below	3 Participants	5 Participants	2 Participants	4 Participants	2 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Within · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Below · Below	1 Participants	1 Participants	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Below · Within	1 Participants	0 Participants	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Below · Above	0 Participants	0 Participants	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Below · Missing	0 Participants	0 Participants	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Within · Below	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Within · Within	19 Participants	23 Participants	21 Participants	22 Participants	8 Participants
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Within · Above	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Within · Missing	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Above · Below	0 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Above · Within	1 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Above · Above	0 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Above · Missing	0 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Within · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Within · Within	9 Participants	5 Participants	8 Participants	13 Participants	4 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Within · Above	6 Participants	8 Participants	4 Participants	3 Participants	1 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Within · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Above · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Above · Within	0 Participants	0 Participants	2 Participants	3 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Above · Above	8 Participants	11 Participants	10 Participants	4 Participants	3 Participants
Number of German Subjects With Different Biochemical and Haematological Levels LDH- Within · Above	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels LDH- Above · Below	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH- Above · Within	1 Participants	3 Participants	1 Participants	1 Participants	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH- Above · Above	1 Participants	2 Participants	3 Participants	0 Participants	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH- Above · Missing	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH- Missing · Below	0 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH- Missing · Within	0 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH- Missing · Above	1 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH- Missing · Missing	0 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels PTPT - Missing · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTPT - Missing · Within	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTPT - Missing · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTPT - Missing · Missing	22 Participants	24 Participants	23 Participants	24 Participants	8 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTT - Missing · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTT - Missing · Within	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTT - Missing · Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels TP - Below · Below	0 Participants	—	0 Participants	—	—
Number of German Subjects With Different Biochemical and Haematological Levels TP - Below · Within	2 Participants	—	1 Participants	—	—
Number of German Subjects With Different Biochemical and Haematological Levels TP - Below · Above	0 Participants	—	0 Participants	—	—
Number of German Subjects With Different Biochemical and Haematological Levels TP - Below · Missing	0 Participants	—	0 Participants	—	—
Number of German Subjects With Different Biochemical and Haematological Levels TP - Within · Below	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels TP - Within · Within	21 Participants	24 Participants	21 Participants	22 Participants	8 Participants
Number of German Subjects With Different Biochemical and Haematological Levels TP - Within · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels TP - Within · Missing	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At one week post-vaccination 2 (Month 2)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=22 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=24 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=24 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=24 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=8 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Within · Below	2 Participants	2 Participants	2 Participants	4 Participants	1 Participants
Number of German Subjects With Different Biochemical and Haematological Levels TP - Below · Within	0 Participants	—	1 Participants	—	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH - Missing · Above	0 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH - Missing · Missing	0 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels PTPT - Missing · Below	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTPT - Missing · Within	18 Participants	22 Participants	20 Participants	19 Participants	8 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTPT - Missing · Above	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Below · Below	4 Participants	6 Participants	8 Participants	6 Participants	2 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Below · Within	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Below · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Below · Missing	3 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Within · Within	12 Participants	15 Participants	11 Participants	12 Participants	5 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Within · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels ALB - Within · Missing	2 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Below · Below	1 Participants	0 Participants	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Below · Within	0 Participants	1 Participants	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Below · Above	0 Participants	0 Participants	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Below · Missing	1 Participants	0 Participants	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Within · Below	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Within · Within	16 Participants	23 Participants	20 Participants	22 Participants	8 Participants
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Within · Above	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Within · Missing	4 Participants	0 Participants	2 Participants	2 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Above · Below	0 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Above · Within	1 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Above · Above	0 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels CAL - Above · Missing	0 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Within · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Within · Within	8 Participants	8 Participants	6 Participants	11 Participants	4 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Within · Above	5 Participants	5 Participants	5 Participants	3 Participants	1 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Within · Missing	2 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Above · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Above · Within	0 Participants	1 Participants	3 Participants	1 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Above · Above	6 Participants	10 Participants	8 Participants	7 Participants	3 Participants
Number of German Subjects With Different Biochemical and Haematological Levels FIB - Above · Missing	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels LDH - Within · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels LDH - Within · Within	14 Participants	16 Participants	15 Participants	20 Participants	8 Participants
Number of German Subjects With Different Biochemical and Haematological Levels LDH - Within · Above	2 Participants	3 Participants	3 Participants	1 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels LDH - Within · Missing	5 Participants	0 Participants	2 Participants	2 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels LDH - Above · Below	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH - Above · Within	0 Participants	4 Participants	1 Participants	1 Participants	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH - Above · Above	2 Participants	1 Participants	3 Participants	0 Participants	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH - Above · Missing	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH - Missing · Below	0 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels LDH - Missing · Within	1 Participants	—	—	—	—
Number of German Subjects With Different Biochemical and Haematological Levels PTPT - Missing · Missing	3 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTT - Missing · Below	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTT - Missing · Within	18 Participants	23 Participants	22 Participants	20 Participants	8 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTT - Missing · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels PTT - Missing · Missing	3 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels TP - Below · Below	0 Participants	—	0 Participants	—	—
Number of German Subjects With Different Biochemical and Haematological Levels TP - Below · Above	0 Participants	—	0 Participants	—	—
Number of German Subjects With Different Biochemical and Haematological Levels TP - Below · Missing	2 Participants	—	0 Participants	—	—
Number of German Subjects With Different Biochemical and Haematological Levels TP - Within · Below	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels TP - Within · Within	19 Participants	24 Participants	19 Participants	20 Participants	8 Participants
Number of German Subjects With Different Biochemical and Haematological Levels TP - Within · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of German Subjects With Different Biochemical and Haematological Levels TP - Within · Missing	3 Participants	0 Participants	2 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented, who filled in their symptom sheets.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=164 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=166 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=54 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	94 Participants	11 Participants	99 Participants	2 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	40 Participants	49 Participants	43 Participants	1 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	2 Participants	2 Participants	3 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	26 Participants	21 Participants	24 Participants	3 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	1 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	99 Participants	93 Participants	99 Participants	93 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	4 Participants	3 Participants	3 Participants	3 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	51 Participants	54 Participants	52 Participants	48 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	1 Participants	3 Participants	2 Participants	2 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	30 Participants	23 Participants	30 Participants	27 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	115 Participants	12 Participants	122 Participants	93 Participants	9 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	4 Participants	3 Participants	6 Participants	3 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	68 Participants	66 Participants	68 Participants	49 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	2 Participants	5 Participants	4 Participants	2 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	44 Participants	33 Participants	45 Participants	30 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	1 Participants	2 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented, who filled in their symptom sheets.

Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=164 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=166 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=54 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	36 Participants	48 Participants	46 Participants	20 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Across doses	66 Participants	80 Participants	67 Participants	46 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	1 Participants	2 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	30 Participants	34 Participants	34 Participants	12 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	7 Participants	7 Participants	5 Participants	4 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	7 Participants	5 Participants	3 Participants	4 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	23 Participants	25 Participants	24 Participants	13 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	19 Participants	17 Participants	13 Participants	6 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 1	48 Participants	57 Participants	46 Participants	11 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 1	1 Participants	2 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 1	41 Participants	52 Participants	41 Participants	10 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	56 Participants	70 Participants	52 Participants	38 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	2 Participants	6 Participants	4 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	47 Participants	48 Participants	43 Participants	27 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	13 Participants	13 Participants	18 Participants	5 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	12 Participants	12 Participants	18 Participants	5 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	39 Participants	47 Participants	39 Participants	27 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	2 Participants	3 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	32 Participants	32 Participants	35 Participants	21 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 2	59 Participants	71 Participants	59 Participants	46 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 2	4 Participants	7 Participants	4 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 2	52 Participants	61 Participants	57 Participants	41 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	69 Participants	85 Participants	73 Participants	47 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	3 Participants	7 Participants	6 Participants	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	57 Participants	60 Participants	59 Participants	33 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across doses	19 Participants	18 Participants	22 Participants	9 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	18 Participants	15 Participants	20 Participants	9 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	47 Participants	59 Participants	51 Participants	36 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	2 Participants	3 Participants	4 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	39 Participants	41 Participants	42 Participants	25 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Across doses	74 Participants	89 Participants	70 Participants	49 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Across doses	5 Participants	8 Participants	6 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: From Month 0 to Month 3

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.

Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=164 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=166 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=54 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Month 3 up to Month 36

Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=156 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=159 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=159 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=161 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=50 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes Month 3 - Month 12	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes Month 12 - Month 24	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes Month 24 - Month 36	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: During the 30-day (Days 0-29) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=164 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=166 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=54 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	7 Participants	10 Participants	10 Participants	5 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	55 Participants	52 Participants	54 Participants	41 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	20 Participants	22 Participants	24 Participants	13 Participants	2 Participants

SECONDARY outcome

Timeframe: From Month 0 to Month 3

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=164 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=166 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=165 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=54 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Number of Subjects With Serious Adverse Events (SAEs)	2 Participants	4 Participants	3 Participants	6 Participants	3 Participants

SECONDARY outcome

Timeframe: From Month 3 to Month 12

Outcome measures

Outcome measures
Measure	GSK1437173A _LD Group n=156 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=159 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=159 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=161 Participants Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A_MODIFIED Group n=50 Participants Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Number of Subjects With Serious Adverse Events (SAEs) Month 3 - Month 12	11 Participants	14 Participants	11 Participants	16 Participants	3 Participants
Number of Subjects With Serious Adverse Events (SAEs) Month 12 - Month 24	21 Participants	27 Participants	29 Participants	25 Participants	11 Participants
Number of Subjects With Serious Adverse Events (SAEs) Month 24 - Month 36	19 Participants	12 Participants	25 Participants	20 Participants	5 Participants

Adverse Events

GSK1437173A _LD Group

Serious events: 53 serious events

Other events: 134 other events

Deaths: 2 deaths

GSK1437173A _MD Group

Serious events: 57 serious events

Other events: 142 other events

Deaths: 3 deaths

GSK1437173A _HD Group

Serious events: 68 serious events

Other events: 140 other events

Deaths: 3 deaths

Placebo + GSK1437173A _HD Group

Serious events: 67 serious events

Other events: 124 other events

Deaths: 5 deaths

Placebo Group

Serious events: 22 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	GSK1437173A _LD Group n=164 participants at risk Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=166 participants at risk Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=165 participants at risk Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=165 participants at risk Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo Group n=54 participants at risk Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian fibroma	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Blood and lymphatic system disorders Anaemia	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Acute myocardial infarction	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Angina pectoris	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	2.4% 4/165 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.8% 3/165 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Angina unstable	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Arrhythmia supraventricular	0.61% 1/164 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Atrial fibrillation	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.8% 3/165 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Atrial flutter	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Atrioventricular block	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Atrioventricular block first degree	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Bradyarrhythmia	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	5.6% 3/54 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Cardiac failure	1.8% 3/164 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	3.7% 2/54 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Cardiac failure congestive	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Cardiomyopathy	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Coronary artery disease	1.8% 3/164 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/165 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Coronary artery stenosis	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Myocardial infarction	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/165 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Myocardial ischaemia	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/165 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Right ventricular failure	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Sick sinus syndrome	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Sinoatrial block	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Cardiac disorders Tachyarrhythmia	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Congenital, familial and genetic disorders Gastrointestinal angiodysplasia	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Ear and labyrinth disorders Meniere's disease	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Ear and labyrinth disorders Vertigo	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Ear and labyrinth disorders Vestibular disorder	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Endocrine disorders Hyperthyroidism	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Eye disorders Cataract	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Eye disorders Retinal detachment	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Eye disorders Retinal vein thrombosis	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Colitis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Colitis ulcerative	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Crohn's disease	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Diabetic gastropathy	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Duodenal ulcer	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Enteritis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Gastric ulcer	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Gastritis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Ileus paralytic	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Inguinal hernia	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.8% 3/166 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Intestinal polyp	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Pancreatitis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Pancreatitis acute	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Peptic ulcer perforation	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Rectal prolapse	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Subileus	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Tooth disorder	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
General disorders Chest pain	1.2% 2/164 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
General disorders Cyst	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
General disorders Device dislocation	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
General disorders Drowning	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
General disorders Gait disturbance	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
General disorders Medical device complication	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Hepatobiliary disorders Bile duct stenosis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Hepatobiliary disorders Bile duct stone	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Hepatobiliary disorders Cholecystitis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/165 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Hepatobiliary disorders Cholelithiasis	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Immune system disorders Allergy to arthropod bite	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Immune system disorders Amyloidosis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Appendicitis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Clostridial infection	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Cystitis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Diabetic gangrene	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Diverticulitis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.8% 3/165 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Erysipelas	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Febrile infection	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Gastroenteritis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Gastroenteritis aeromonas	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Gastroenteritis clostridial	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Helicobacter gastritis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Lymphangitis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Neuroborreliosis	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Pancreatic abscess	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Pneumonia	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Pneumonia primary atypical	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Pseudomembranous colitis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Sinusitis aspergillus	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Upper respiratory tract infection	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Urinary tract infection	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Infections and infestations Urosepsis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Asbestosis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Cervical vertebral fracture	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Contusion	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/165 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Hand fracture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Radius fracture	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Skull fracture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Tendon rupture	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Tooth injury	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Metabolism and nutrition disorders Dehydration	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	3.7% 2/54 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Arthropathy	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Back disorder	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Back pain	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Bone cyst	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Muscle atrophy	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Osteoarthritis	1.2% 2/164 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	3.0% 5/165 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.8% 3/165 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.8% 3/166 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Synovial cyst	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiomyolipoma	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.2% 2/164 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/165 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangiopericytoma	1.2% 2/164 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer stage iii	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/165 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma recurrent	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural mesothelioma	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Carotid artery stenosis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Carpal tunnel syndrome	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Cerebellar infarction	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Cerebral ischaemia	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Cerebrovascular accident	1.2% 2/164 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.8% 3/165 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Cerebrovascular disorder	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Dementia	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Dizziness	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Drop attacks	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Epilepsy	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Haemorrhage intracranial	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Ischaemic stroke	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Neuropathy peripheral	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Partial seizures	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Somnolence	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Syncope	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/165 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Transient ischaemic attack	1.8% 3/164 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	2.4% 4/165 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Vascular encephalopathy	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Viith nerve paralysis	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Psychiatric disorders Depression	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Renal and urinary disorders Glomerulonephritis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Renal and urinary disorders Haematuria	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Renal and urinary disorders Oliguria	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Renal and urinary disorders Renal failure	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Renal and urinary disorders Renal failure acute	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Renal and urinary disorders Stress urinary incontinence	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Renal and urinary disorders Urethral stenosis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Reproductive system and breast disorders Breast pain	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Reproductive system and breast disorders Cystocele	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Reproductive system and breast disorders Prostatitis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Reproductive system and breast disorders Uterine polyp	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Reproductive system and breast disorders Uterine prolapse	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Skin and subcutaneous tissue disorders Rash	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Vascular disorders Aortic aneurysm	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Vascular disorders Aortic stenosis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Vascular disorders Arteriosclerosis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Vascular disorders Circulatory collapse	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Vascular disorders Femoral arterial stenosis	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Vascular disorders Haemorrhage	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Vascular disorders Hypertension	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Vascular disorders Hypertensive crisis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/165 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/165 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Vascular disorders Orthostatic hypotension	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Vascular disorders Peripheral arterial occlusive disease	0.61% 1/164 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.60% 1/166 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Vascular disorders Varicose vein	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.2% 2/166 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Vascular disorders Venous thrombosis	0.00% 0/164 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/166 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.61% 1/165 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).

Other adverse events

Other adverse events
Measure	GSK1437173A _LD Group n=164 participants at risk Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	GSK1437173A _MD Group n=166 participants at risk Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	GSK1437173A _HD Group n=165 participants at risk Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo + GSK1437173A _HD Group n=165 participants at risk Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Placebo Group n=54 participants at risk Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Skin and subcutaneous tissue disorders Erythema	41.5% 68/164 • Number of events 91 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	39.2% 65/166 • Number of events 102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	41.2% 68/165 • Number of events 96 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	30.3% 50/165 • Number of events 50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	3.7% 2/54 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
General disorders Fatigue	42.1% 69/164 • Number of events 92 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	51.2% 85/166 • Number of events 118 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	44.2% 73/165 • Number of events 99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	28.5% 47/165 • Number of events 58 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	22.2% 12/54 • Number of events 17 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Nervous system disorders Headache	29.3% 48/164 • Number of events 65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	36.1% 60/166 • Number of events 73 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	30.9% 51/165 • Number of events 64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	21.8% 36/165 • Number of events 40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	16.7% 9/54 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Musculoskeletal and connective tissue disorders Myalgia	45.7% 75/164 • Number of events 109 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	53.6% 89/166 • Number of events 128 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	42.4% 70/165 • Number of events 105 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	29.7% 49/165 • Number of events 57 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	16.7% 9/54 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
General disorders Pain	70.1% 115/164 • Number of events 193 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	72.9% 121/166 • Number of events 205 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	73.9% 122/165 • Number of events 199 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	56.4% 93/165 • Number of events 95 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	16.7% 9/54 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
General disorders Pyrexia	12.2% 20/164 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	11.4% 19/166 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	13.3% 22/165 • Number of events 23 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	5.5% 9/165 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	0.00% 0/54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
General disorders Swelling	26.2% 43/164 • Number of events 55 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	19.3% 32/166 • Number of events 43 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	27.3% 45/165 • Number of events 54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	18.2% 30/165 • Number of events 30 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).	1.9% 1/54 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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